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Enforcement Report for October 8, 2008

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

October 8, 2008
08-40

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

___________________________________
PRODUCT
Fresh From the Deli American Sub Ham, Salami, Bologna, Swiss and American Cheese on a 8" Seeded Hoagie Bun Sandwich, Half Pounder Plus, Net Wt. 9.75 Oz. (276 g); a refrigerated prepackaged sandwich, individually wrapped in clear plastic with a black tray inside of the package, 8 sandwiches per case; UPC 0 97488 00540 5, Recall # F-576-8
CODE
Lot “2188 2”, “Best if used by” 9/5/08 (or earlier) on label
RECALLING FIRM/MANUFACTURER
Landshire, Inc., Belleville, IL, by press release on August 27, 2008 and August 28, 2008. Firm initiated recall is ongoing.
REASON
The sandwiches were found to be contaminated with Listeria monocytogenes bacteria based on the Ohio Department of Agriculture’s analysis.
VOLUME OF PRODUCT IN COMMERCE
780 sandwiches
DISTRIBUTION
IN, KY, OH and PA
___________________________________
PRODUCT
DRIED ROACH --- Ingredients: Fish, Salt. The product comes in clear, vacuum packed, plastic pouches of various weights. According to the lab report, the vacuum packed package contained 3 whole fish measuring 8 1/8 inches, 10 3/8 inches, and 10 3/4 inches, Recall # F-577-8
CODE
Product code 20.03.08
RECALLING FIRM/MANUFACTURER
Royal Seafood, Far Rockaway, NY, by press release on December 19, 2007. Firm initiated recall is complete.
REASON
The processed fish was uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
98 packages
DISTRIBUTION
NY
___________________________________
PRODUCT
a) Alfalfa sprouts in 4 oz. plastic clamshells, UPC 815098001088, sold 6/case; 5 oz.
plastic cups, UPC 033383701417, sold 12/case; 1 lb. plastic bag (UPC
079566123508); and 2 lb. tray (UPC079566123492). Alfalfa sprouts contain up to
10% clover sprouts, Recall # F-578-8;
b) Salad sprouts in 4 oz. plastic clamshells (UPC 815098002061), sold 6/case; and 5 oz.
plastic cups (UPC 03338370674), sold 12/case. Ingredients: Alfalfa, clover, fenugreek,
lentils and radish, Recall # F-579-8;
c) Onion Sprouts a blend of alfalfa and onion sprouts in 4 oz. clamshell, UPC
815098002054, sold 6/case; and Alfalfa Onion Sprouts in 5 oz. cup, UPC
033383701905, sold 6/case. Ingredients: alfalfa and onion sprouts. Alfalfa and onion
sprouts also contain up to 10% clover sprouts, Recall # F-580-8
CODE
Best by dates 9/17/08 and earlier
RECALLING FIRM/MANUFACTURER
Sprouters Northwest, Inc., Kent, WA, by telephone and letter on September 4, 2008 and by letter on September 5, 2008. Firm initiated recall is complete.
REASON
Products are implicated in an outbreak of Salmonella typhimurium illness.
VOLUME OF PRODUCT IN COMMERCE
35587 alfalfa containers; 4944 salad sprout containers; 4056 alfalfa/onion containers
DISTRIBUTION
WA, OR and AK
___________________________________
PRODUCT
Smoked salmon in clear vacuum sealed bags labeled Santa’s Smokehouse KETA Gourmet Smoked Salmon, Recall # F-599-8
CODE
Batch 637
RECALLING FIRM/MANUFACTURER
Interior Alaska Fish Processor, Fairbanks, AL, by press release on August 13, 2008. Firm initiated recall is complete.
REASON
Product contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
150 lbs.
DISTRIBUTION
AK
___________________________________
PRODUCT
Kroger brand Hulless Corn Puff Poppers - Extreme Butter (Artificially Flavored) in 8 oz metalized bags. UPC 0 11110 09184 0, Recall # F-600-8
CODE
Sell By: NOV 08 08 244A or NOV 08 08 244B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kroger, Co., Cincinnati, OH, by press release and internal e-mail on August 15, 2008.
Manufacturer: Columbus Bakery Division of Kroger Co., Columbus, OH. Firm initiated recall is ongoing.
REASON
Product may contain milk, which is not listed in the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
1,947 cases/9/8 oz. packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Patak’s Original Rich Tomato and Onion Cooking Sauce Dopiaza Mild, Net wt 14.5 oz. (411g); also packaged as Patak’s Original Dopiaza Curry Cooking Sauce, Mild, Net wt 15 oz. (425g). Unit UPC 0-69276-07005-6 case UPC 050-11308-14001-0, Recall # F-601-8
CODE
Best By date of February 2010 or before
RECALLING FIRM/MANUFACTURER
Recalling Firm: ACH Food Companies, Inc., Ankeny, IA, by telephone on August 27, 2008, by press release and letters on September 4, 2008.
Manufacturer: Patak’s Foods, Ltd., Haydock Lancs, UK. Firm initiated recall is ongoing.
REASON
Product contains an undeclared milk ingredient, butter.
VOLUME OF PRODUCT IN COMMERCE
7,019 cases of 6 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Hershey’s Chocolate Shell Topping in 7.25 oz. plastic bottles; UPC 0346007. The product is shipped in cases containing 12 bottles. The mislabeled bottles were shipped in cases labeled as Heath Shell Topping, Recall # F-602-8
CODE
Lot number: 69N
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Hershey Company, Hershey, PA, by press release and letter on September 4, 2008.
Manufacturer: Southern Classic Food Group LLC, Brundidge, AL. Firm initiated recall is ongoing.
REASON
Product contains undeclared almonds.
VOLUME OF PRODUCT IN COMMERCE
1,700 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Girard’s Honey Dijon Peppercorn Dressing, 12 fl. Oz. glass jar; UPC 0 70200 58105 0, Recall # F-603-8
CODE
Best By 06-11-09M
RECALLING FIRM/MANUFACTURER
Recalling Firm: T Marzetti, Co., Columbus, OH, by press release and letters on September 4, 2008
Manufacturer: T Marzetti Company-West, Milpitas, CA. Firm initiated recall is ongoing.
REASON
Product contains undeclared egg.
VOLUME OF PRODUCT IN COMMERCE
285 cases/6/12 oz. glass jars
DISTRIBUTION
CA, OR and WA
___________________________________
PRODUCT
Fresh To You” Albacore Tuna Salad Hoagies, 7 oz. size packaged in three compartment black plastic trays, heat-sealed with clear plastic film and branded with a stick-on label. The sandwiches are distributed under refrigeration in delivery truck coolers, Recall # F-604-8
CODE
Expiration Date: 9-17-08
RECALLING FIRM/MANUFACTURER
Derringer Food Service, Cincinnati, OH, by telephone on September 12, 2008 and by press release on September 17, 2008. Firm initiated recall is ongoing.
REASON
Product contains undeclared egg.
VOLUME OF PRODUCT IN COMMERCE
562 trays
DISTRIBUTION
OH, KY
___________________________________
PRODUCT
a) Sindoor powder; the product is distributed in a 3.5 oz. (100 Gms) plastic bag, 20 bags
per case; The bags are labeled with a front label stating "Swad Best Taste in Town
Sindoor", and "PRODUCT OF INDIA" with a UPC of 0 51179 42236 0 and may
have a sticker stating "NONEDIBLE", Recall # F-605-8;
b) Lagan Samagri is a 1.3 Kg. (45.61 oz.) kit which includes bags of Sindoor, Gulal and
Abil powders; The kits are labeled with a front label stating "SWAD Best Taste in
Town Lagan Samagri", "Product of India", UPC of 0 51179 42080 9 and may have a
sticker stating "Non-Edible Product", Recall # F-609-8
CODE
All packages
RECALLING FIRM/MANUFACTURER
Recalling Firm: Raja Foods, L.L.C. Skokie, IL, by letters dated December 13, 2007 and December 28, 2007.
Manufacturer: Kitchen Xpress Overseas, LTD, Tal Sanei Kalol 382 721, Gandhinagar, India. Firm initiated recall is ongoing.
REASON
Products contained excessive levels of lead in the Sindor powder based on the Illinois Department of Public Health's analysis.
VOLUME OF PRODUCT IN COMMERCE
959 cases and 317 kits
DISTRIBUTION
Nationwide, Panama, Jamaica and St. Maarten

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

___________________________________
PRODUCT
a) All varieties of Wegmans in-store made bagels sold individually in the bakery section
of Wegmans stores, and purchased between June 19 and September 11, 2008. The
bulk, raw, unbaked, formed bagels were shipped frozen from Wegmans' Central
Bakeshop to Wegmans stores. The stores will top them, bake them, and display them
for sale to the general public as several different varieties. The bulk bagels were
shipped frozen to Wegmans stores in bulk cases labeled in part, "*** Plain Bagels
57221 PK105 *** date (xx/xx/xx) *** #20 ***". Commodity Code 57221 for
shipping/tracking use only, Recall # F-583-8
b) All varieties of Wegmans in-store made bialys (flattened bagels with various
toppings, i.e. pizza) sold individually in the bakery section of Wegmans stores, and
purchased between June 19 and September 11, 2008. The bulk, raw, unbaked, formed
bagels were shipped frozen from Wegmans' Central Bakeshop to Wegmans stores.
The stores will top them, bake them, and display them for sale to the general public
as several different varieties, including bialy_s (flattened bagels with various
toppings), Recall # F-584-8;
c) Wegmans Bakery Food You Feel Good About brand Bagels Assorted, Net Wt 21 oz.
(1 lb. 5 oz.), 595g, UPC 77890 62807. The bagels are shipped frozen from Wegmans'
Central Bakeshop to Wegmans stores where they are baked in-store and packaged.
The labels are provided by Wegmans Corp. The bagels were sold pre-packaged, 6
bagels per package, Recall # F-585-8;
d) Wegmans Bakery Food You Feel Good About brand Bagels Cinnamon Raisin, Net
Wt. 21 oz. (1 lb. 5 oz.), 595 g, UPC 77890 62804. The bagels are shipped frozen
from Wegmans' Central Bakeshop to Wegmans stores where they are baked in-store
and packaged. The labels are provided by Wegmans Corp. The bagels were sold pre-
packaged, 6 bagels per package, Recall # F-586-8;
e) Wegmans Bakery Food You Feel Good About brand Bagels Honey Wheat, Net Wt
21oz. (1 lb. 5 oz), 595g, UPC 77890 62816. The bagels are shipped frozen from
Wegmans' Central Bakeshop to Wegmans stores where they are baked in-store and
packaged. The labels are provided by Wegmans Corp. The bagels were sold pre-
packaged, 6 bagels per package, Recall # F-587-8;
f) Wegmans Bakery Food You Feel Good About brand Bagels Plain, Net Wt 21 oz.
(1 lb 5 oz), 595g, UPC 77890 62786. The bagels are shipped frozen from Wegmans'
Central Bakeshop to Wegmans stores where they are baked in-store and packaged.
The labels are provided by Wegmans Corp. The bagels were sold pre-packaged, 6
bagels per package, Recall # F-588-8;
g) Wegmans Bakery Food You Feel Good About brand Bagels Sesame, Net Wt 21 oz
(1 lb 5 oz), 595g, UPC 77890 62795. The bagels are shipped frozen from Wegmans'
Central Bakeshop to Wegmans stores where they are baked in-store and packaged.
The labels are provided by Wegmans Corp. The bagels were sold pre-packaged, 6
bagels per package, Recall # F-589-8;
h) Wegmans Bakery Food You Feel Good About brand Challah Rolls, Net Wt 12 oz.
340g, UPC 77890 85195. The rolls are received frozen from Wegmans' Central
Bakeshop and baked in the store. The rolls are packaged at the store after they are
baked. The labels are provided by Wegmans Corp. The rolls were sold pre-packaged,
6 rolls per package, Recall # F-590-8;
i) Wegmans Bakery brand Dinner Rolls, Net Wt. 16 oz. (1 lb.), 454g, UPC 77890 75813.
The rolls are received frozen from Wegmans' Central Bakeshop and baked in the
store. The rolls are packaged at the store after they are baked. The labels are provided
by Wegmans Corp. The rolls were sold pre-packaged, 12 rolls per package, Recall #
F-591-8;
j) Wegmans Bakery Food You Feel Good About brand Golden Sub Rolls, Net Wt. 12 oz.
340g, UPC 77890 58953. The rolls are received frozen from Wegmans' Central
Bakeshop and baked in the store. The rolls are packaged at the store after they are
baked. The labels are provided by Wegmans Corp. The rolls were sold pre-packaged,
6 rolls per package, Recall # F-592-8;
k) Wegmans Bakery brand Kaiser Rolls, Net Wt. 14 oz., 397g, UPC 77890 28697, and
Mini Kaiser Rolls sold individually only. The rolls are received frozen from Wegmans'
Central Bakeshop and baked in the store. Except for the mini kaiser rolls, the kaiser
rolls are packaged at the store after they are baked. The labels are provided by
Wegmans Corp. The kaiser rolls were sold individually or pre-packaged, 6 rolls per
package, Recall # F-593-8;
l) Wegmans Bakery Food You Feel Good About brand Onion Rolls, Net Wt. 9 oz, 255g,
UPC 77890 75720. The rolls are received frozen from Wegmans' Central Bakeshop
and baked in the store. The rolls are packaged at the store after they are baked. The
labels are provided by Wegmans Corp. The rolls were sold pre-packaged, 6 rolls per
package, Recall # F-594-8;
m) Wegmans Bakery brand Submarine Rolls, Net Wt. 12 oz. 340 g, UPC 77890 28715.
The rolls are received frozen from Wegmans' Central Bakeshop and baked in the
store. The rolls are packaged at the store after they are baked. The labels are provided
by Wegmans Corp. The rolls were sold pre-packaged, 6 rolls per package, Recall #
F-595-8;
n) Wegmans Bakery brand Super Soft Vienna Rolls, Net Wt. 18 oz. (1 lb. 2 oz), 510g,
UPC 77890 12391. The rolls are received frozen from Wegmans' Central Bakeshop
and baked in the store. The rolls are packaged at the store after they are baked. The
labels are provided by Wegmans Corp. The rolls were sold pre-packaged, 6 rolls per
package, Recall # F-596-8;
o) Wegmans Bakery, Food You Feel Good About brand Wheat Rolls, Net Wt 12 oz,
340g, UPC 77890 82778. The rolls are received frozen from Wegmans' Central
Bakeshop and baked in the store. The rolls are packaged at the store after they are
baked. The labels are provided by Wegmans Corp. The rolls were sold pre-packaged,
6 rolls per package, Recall # F-597-8
CODE
Uncoded; sold between June 19 and September 11, 2008
RECALLING FIRM/MANUFACTURER
Wegmans Food Markets, Rochester, NY, by email on September 9, 2008 and by press release on September 10 and September 12, 2008. Firm initiated recall is ongoing.
REASON
Products may contain metal fragments.
VOLUME OF PRODUCT IN COMMERCE
Approximately 105,309 cases
DISTRIBUTION
NY, NJ, PA, VA and MD

RECALLS AND FIELD CORRECTIONS: FOODS and COSMETICS - CLASS III

___________________________________
PRODUCT
Just 4 Girls Cosmetic Set, body glitter, 2.75 oz (76g), SKU 2041799, UPC 026041318218, Recall # F-581-8
CODE
Not coded
RECALLING FIRM/MANUFACTURER
Recalling Firm: Family Dollar Services, Inc., Charlotte, NC, by email on June 25, 2008.
Manufacturer: China, New York, NY. Firm initiated recall is complete.
REASON
The product was found to be contaminated with mold.
VOLUME OF PRODUCT IN COMMERCE
18,824 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
"Frozen Chilli piment Congele" that was vacuum packed in a plastic bag with a multicolored label that reads, "***New Town Frozen Chilli piment Congele***ING : Chilli***Net Wt : 6 oz / POIDS Net : 170gr PRODUCT OF VIETNAM.”*** The retail unit is stored inside master cartons which are brown colored cardboard boxes that have labeling which reads, "FROZEN CHILLI Net Wt: 100 x 6 oz (170g)***PRODUCT OF VIETNAM***", Recall # F-582-8
CODE
All production and lot codes sold between November 2007 and the end of March 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: H & T Seafood, Inc., Bell, CA, by letter on April 10, 2008.
Manufacturer: MY THANH CO., Ltd., Ho Chih Minh City, Vietnam. Firm initiated recall is ongoing.
REASON
Product contains pesticide residues - propiconazole, profenofos, and difenoconazole - based on FDA's analysis.
VOLUME OF PRODUCT IN COMMERCE
190 cartons x 100pk x 6 oz
DISTRIBUTION
CA, IL, KS, NV & UT
___________________________________
PRODUCT
VOLT”, Guarana +Taurine, Energizing Citrus Shock, 20 fl. oz. (591 mL), UPC 0 47097 00005 6, Recall # F-598-8
CODE
7092, Exp. date: July 2, 2007; 7144, Exp. date: August 12, 2007; and 7148, Exp. Date: August 14, 2007.
RECALLING FIRM/MANUFACTURER
Pauls Beverages, New Castle, PA, by telephone, e-mails and visits from August 28, 2007 to September 6, 2007. Firm initiated recall is complete.
REASON
Product has an off-taste and off-odor.
VOLUME OF PRODUCT IN COMMERCE
2,268 cases (24 units per case)
DISTRIBUTION
NC, OH, VA
___________________________________
PRODUCT
a) Gulal powder; the product is distributed in a 3.5 oz. (100 Gms) plastic bag, 20 bags
per case; The bags are labeled with a front label stating "Swad Best Taste In Town
Gulal", and "Product of India", with a UPC of 0 51179 42222 3 and may have a
sticker stating "NON EDIBLE", Recall # F-606-8;
b) Abil powder; the product is distributed in a 3.5 oz. (100 Gms) plastic bag, 20 bags per
case; The bags are labeled with a front label stating " Swad Best Taste In Town Abil",
and "Product of India", with a UPC of 0 51179 42214 8 and may have a sticker stating
"NON EDIBLE", Recall # F-607-8;
c) Kanku powder also known as Red Kum Kum; the product is distributed in a 3.5 oz.
(100 Gms) plastic bag, 20 bags per case; The bags are labeled with a front label
stating "Swad Best Taste in Town Red Kum Kum", and "Product of India", with a
UPC of 0 51179 42202 5 and may have a sticker stating "NON EDIBLE". Recall #
F-608-8
CODE
All packages
RECALLING FIRM/MANUFACTURER
Recalling Firm: Raja Foods, L.L.C. Skokie, IL, by letters dated December 13, 2007 and December 28, 2007.
Manufacturer: Kitchen Xpress Overseas, LTD, Tal Sanei Kalol 382 721, Gandhinagar, India. Firm initiated recall is ongoing.
REASON
Products contained low levels of lead based on the Illinois Department of Public Health's analysis.
VOLUME OF PRODUCT IN COMMERCE
959 cases and 317 kits
DISTRIBUTION
Nationwide, Panama, Jamaica and St. Maarten

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

___________________________________
PRODUCT
Strovite Tablets, 100 Tablet bottles, Rx only, NDC 00642-0200-10. Recall # D-376-2008
CODE
Lot #: 60456A2, Exp. 5/08; 60904A2, Exp. 10/08; 70184A1, Exp. 2/09; 70923A2, Exp. 10/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Everett Laboratories, Inc., West Orange, NJ, by letters on June 10, 2008.
Manufacturer: Actavis Totowa LLC, Totowa, NJ. Firm initiated recall is ongoing.
REASON
cGMP Deviation; Lack of stability indicating methods by manufacturer.
VOLUME OF PRODUCT IN COMMERCE
11,820 bottles x 100 tablets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ampicillin and Sulbactam for injection, USP, Pharmacy Bulk Package, Not for Direct Infusion, NOVAPLUS; NDC # 10019-638-03, Recall # D-377-2008
CODE
Lot #: P2168, Exp. December 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated July 2, 2008.
Manufacturer: G. C. Hanford Manufacturing Co., Syracuse, NY. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter.
VOLUME OF PRODUCT IN COMMERCE
4,197 vials
DISTRIBUTION
Nationwide

**** CORRECTION ****

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

From October 1, 2008, Enforcement report: Product: c) Medtronic Sutureless Pump Connector Revision Kit, model 8678, Recall # Z-2382-2008; Should be Model 8578.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT
NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator, Recall # Z-0071-2008
CODE
Lot Number 061205-1; Serial Numbers: 10117, 10119, 10120, 10122, 10124, 100129, and 10133
RECALLING FIRM/MANUFACTURER
Neomedix Corp., Tustin, CA, by letter on May 31, 2007. Firm initiated recall is complete.
REASON
Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confirmed one instance of a valve that did not open. The electrically activated pinch valve in the NeoMedix Trabectome I/A pump activates irrigation flow to the eye during Trabectome surgery.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA, HI, IA, NY and PA
___________________________________
PRODUCT
GE Healthcare OEC 9900 mobile fluoroscopic x-ray system, Recall # Z-0368-2008
CODE
All codes
RECALLING FIRM/MANUFACTURER
OEC Medical Systems, Inc., Salt Lake City, UT, by letter on December 15, 2007. Firm initiated recall is ongoing.
REASON
Possible overexposure: Failure to apply the entrance exposure rate (EER) tube current limit calibration to the automatic exposure rate (AER) control system when the anatomical profile mode is changed from the default selection to another selection. Manual technique modes are not affected.
VOLUME OF PRODUCT IN COMMERCE
710 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) GE Healthcare Innova 3100 Digital Fluoroscopic Imaging System with Bolus Chasing
option, Recall # Z-1516-2008;
b) GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus
Chasing option, Recall # Z-1517-2008
CODE
a) 8613100, 77573841, 0910064009, 3018774100, 4103323100, 4103374100, 4103623100, 4105434100, 4438494100, 5138534100, 5703214100, 7083333100, 7278253100, 8019643100, 8595724100, 9408984100, 082416040017, 082416070004, 082416120006, 082416130013, 082416140003, 201541LAB2, 229228INNOV41V, 239436CATH1, 251435ICV5, 270688INN, 304255INNOVA, 304347INNOVA, 309691P3100, 310423INNOVA1, 313593IC1, 313593IC2, 314525SACL2, 315448RM4, 315448RM5, 316268INNOVAA, 319338VA4100, 325670CATH, 334286BSP, 352333VASC, 352376SP, 352401CATH, 352401VASC, 378INV31, 407SPECIALS, 409899LAB3, 413447CATH, 414961INN4100, 416756INNOVA, 417269SCLD, 478633INOV, 502587LAB4, 508856OR41, 516562INNOVA4, 516663INNOVA2, 518525LAB1, 540953INNOVA, 561266IN31, 563421CATHLAB8, 573632CRA, 573761SMA, 573815BCR1, 574535IN41, 574647IN41, 6012884100SP1, 601553CL3, 602239LAB4, 602239LAB6, 603778ECL1, 606833INNOVA, 614293LIBERTY1, 614293LIBERTY2, 615338CV2, 615769SKYCV2, 619340VA8, 619482INNOVA1, 619541INNOVA31, 619552INNOVA1, 626359INNOVA, 702616INNOVA, 7028803100A, 706774CCL5, 713794LAB7, 713794LAB9, 715369INN4100, 717217INN31, 717763INNOVA41, 717763OR4100, 718283INNOVA3, 718518CVL1, 724656ANG, 724773C1, 727725SPEC1, 731422CV1, 732294INOV, 757398INNOVA, 757736INNOVA, 765453INNOVA1, 770991CL3, 773792CL3100, 773NORWG3100, 803329CL31, 803329CL41, 804594CATH, 808547QCV2A, 812238LIB1, 812279INNOVA1, 812283IN31, 812450EP1, 812482INNOVA, 813972INTV, 816276SP1, 817255NH4100, 817433HSW3100, 83INNOVA1188379, 845365V19, 850678IN3100, 865541CCL5, 865693CCL3, 901726SP2, 903CSM4100, 904202CATH3, 904276SP, 908522LAB1, 909788INNOVA1, 918307SHIN4, 918744JC4100, 928779INNOVA1, 936266CL1, 956389INN31, 956632INN4100, 956994INN1, 956994INN2, 972487ANGIO1, 973971LAB3, BPINNOVA2, BPINNOVA3R, BPINNOVA3R, ECXV1406C, FHORLCL1, HC1536XR04, RU1550VA01, RU2457VA01, SLIN4100, YV0022, and YV0036;

b) 8613100, 77573841, 0910064009, 3018774100, 4103323100, 4103374100, 4103623100, 4105434100, 4438494100, 5138534100, 5703214100, 7083333100, 7278253100, 8019643100, 8595724100, 9408984100, 082416040017, 082416070004, 082416120006, 082416130013, 082416140003, 201541LAB2, 229228INNOV41V, 239436CATH1, 251435ICV5, 270688INN, 304255INNOVA, 304347INNOVA, 309691P3100, 310423INNOVA1, 313593IC1, 313593IC2, 314525SACL2, 315448RM4, 315448RM5, 316268INNOVAA, 319338VA4100, 325670CATH, 334286BSP, 352333VASC, 352376SP, 352401CATH, 352401VASC, 378INV31, 407SPECIALS, 409899LAB3, 413447CATH, 414961INN4100, 416756INNOVA, 417269SCLD, 478633INOV, 502587LAB4, 508856OR41, 516562INNOVA4, 516663INNOVA2, 518525LAB1, 540953INNOVA, 561266IN31, 563421CATHLAB8, 573632CRA, 573761SMA, 573815BCR1, 574535IN41, 574647IN41, 6012884100SP1, 601553CL3, 602239LAB4, 602239LAB6, 603778ECL1, 606833INNOVA, 614293LIBERTY1, 614293LIBERTY2, 615338CV2, 615769SKYCV2, 619340VA8, 619482INNOVA1, 619541INNOVA31, 619552INNOVA1, 626359INNOVA, 702616INNOVA, 7028803100A, 706774CCL5, 713794LAB7, 713794LAB9, 715369INN4100, 717217INN31, 717763INNOVA41, 717763OR4100, 718283INNOVA3, 718518CVL1, 724656ANG, 724773C1, 727725SPEC1, 731422CV1, 732294INOV, 757398INNOVA, 757736INNOVA, 765453INNOVA1, 770991CL3, 773792CL3100, 773NORWG3100, 803329CL31, 803329CL41, 804594CATH, 808547QCV2A, 812238LIB1, 812279INNOVA1, 812283IN31, 812450EP1, 812482INNOVA, 813972INTV, 816276SP1, 817255NH4100, 817433HSW3100, 83INNOVA1188379, 845365V19, 850678IN3100, 865541CCL5, 865693CCL3, 901726SP2, 903CSM4100, 904202CATH3, 904276SP, 908522LAB1, 909788INNOVA1, 918307SHIN4, 918744JC4100, 928779INNOVA1, 936266CL1, 956389INN31, 956632INN4100, 956994INN1, 956994INN2, 972487ANGIO1, 973971LAB3, BPINNOVA2, BPINNOVA3R, BPINNOVA3R, ECXV1406C, FHORLCL1, HC1536XR04, RU1550VA01, RU2457VA01, SLIN4100, YV0022, and YV0036
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letter on November 15, 2007.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
Incorrect dose data: After 6 days and 4 hours without performing a system reset or a system reboot (turning it off/on), the displayed dose data on these systems (Innova 3100 / Innova 4100 with Bolus option) may be underestimated by up to 50%. In order to avoid this issue, it is necessary to perform a system reset or reboot every day. GE Healthcare is working on a correction that will be installed on affected units.
VOLUME OF PRODUCT IN COMMERCE
146 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral
Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-
27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35-07-57-080, PXB35-08-17-
080, PXB35-08-17-135, PXB35-08-37-080, PXB35-08-57-080, PXB35-09-17-135,
PXB35-09-27-080, PXB35-09-27-135, PXB35-09-57-080, PXB35-10-27-135, and
PXB35-10-37-080, Recall # Z-1547-2008;
b) ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System.
Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-
08-17-080, PXB35-08-27-135, PXB35-08-37-135, PXB35-08-57-080, and PXB35-
09-17-135 4800, Recall # Z-1548-2008
CODE
a) Lot Numbers: 3273766, 3273767, 3509137, 4218926, 4361370, 4472112, 4941116,
5012047, 5282885, and 5834997;
b) Lot Numbers: 4089374, 4140341, 4151887, 4194358, 4239470, 4251836, 4484043,
44804047, 4491290, 4933989, 5005731, 5012045, 5045725, 5117532, 5147416,
5149205, 5214432, 5221941, 5239429, and 5577902
RECALLING FIRM/MANUFACTURER
Ev3, Inc, Plymouth, MN, by letter dated July 1, 2008. Firm initiated recall is ongoing.
REASON
Specific lots of the Visi-Pro" BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended.
VOLUME OF PRODUCT IN COMMERCE
278 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48, Recall # Z-1612-2008
CODE
Serial numbers all starting with H48 (model number): 6509, 6974, 6616, 6688, 6806, 6568, 6530, 6839, 6740, 7178, 6700, 6694, 6505, 6924, 6979, 6715, 6556, 6757, 6820, 6545, 6564, 7027, 6783, 6553, 6760, 6904, 6907, 7037, 6639, 7088, 6702, 6659, 6940, 6802, 6856, 6944, 6841, 6870, 6874, 6928, 6913, 6614, 7009, 6951, 6493, 6758, 7030, 6453, 6704, 6555, 6691, 6914, 6739, 6846, 6685, 6473, 7015, 6875, 6566, 6599, 6818, 7020, 6799, 6804, 6699, 7075, 6901, 6827, 6833, 6681, 6724, 6499, 6698, 6722, 7018, 6782, 6893, 6522, 6937, 6708, 6560, 6977, 6978, 6803, 6961, 6503, 6814, 7029, 6707, 6686
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter dated February 13, 2008.
Manufacturer: Varian Medical Systems, Finland 04, Helsinki, Finland. Firm initiated recall is ongoing.
REASON
A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan.
VOLUME OF PRODUCT IN COMMERCE
90 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Recall # Z-1692-2008
CODE
4-070523-SP Battery Assembly 4-840120DIUU-US 4-070520-SP BPS
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien Limited, Boulder, CO, by letter dated March 21, 2008 and by visits on/about March 25, 2008.
Manufacturer: Nelicor Puritan Bennett Ireland, Ltd., Galway, Ireland. Firm initiated recall is complete.
REASON
Wiring in battery back-up power supply may short and cause thermal damage to ventilator.
VOLUME OF PRODUCT IN COMMERCE
6 Ventilator units and 151 factory replacement units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed
tomography x-ray system, Recall # Z-1707-2008;
b) Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed
tomography x-ray system, Recall # Z-1708-2008
CODE
All codes
RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems, Inc., Tustin, CA, by letter in July 2007. Firm initiated recall is ongoing.
REASON
Excessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used.
VOLUME OF PRODUCT IN COMMERCE
1203 units
DISTRIBUTION
Nationwide and Japan
___________________________________
PRODUCT
Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system, Recall # Z-1751-2008
CODE
All units with version 6.0 software
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, USA, Inc., Ann Arbor, MI, by a safety advisory on February 8, 2008. Firm initiated recall is ongoing.
REASON
Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient’s file.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number
8515520 equipped with a Digital Electron Variable Applicator (DEVA, Part Number
8485971) with available energy of 6 MeV. Medical charged-particle radiation therapy
system, Recall # Z-1753-2008;
b) Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator, part
number 9411588 equipped with a Digital Electron Variable Applicator (DEVA, Part
Number 8485971) with available energy of 6 MeV. Medical charged-particle
radiation therapy system, Recall # Z-1754-2008;
c) Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number
9822685 equipped with a Digital Electron Variable Applicator (DEVA, Part Number
8485971) with available energy of 6 MeV. Medical charged-particle radiation
therapy system, Recall # Z-1755-2008;
d) Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator, part
number 9822693 equipped with a Digital Electron Variable Applicator (DEVA, Part
Number 8485971) with available energy of 6 MeV. Medical charged-particle
radiation therapy system, Recall # Z-1756-2008;
e) Siemens Medical Solutions, Mevatron KD2 Digital Linear Accelerator, part number
1940753 equipped with a Digital Electron Variable Applicator (DEVA, Part Number
8485971) with available energy of 6 MeV, Recall # Z-1757-2008;
f) Siemens Medical Solutions, Mevatron M2/ Primus Mid Digital Linear Accelerator,
part number 1940035 equipped with a Digital Electron Variable Applicator (DEVA,
Part Number 8485971) with available energy of 6 MeV, Recall # Z-1758-2008;
g) Siemens Medical Solutions, PRIMUS Plus Digital Linear Accelerator, part number
4504200 equipped with a Digital Electron Variable Applicator (DEVA, Part Number
8485971) with available energy of 6 MeV, Recall # Z-1759-2008;
h) Siemens Medical Solutions, ONCOR IMPRESSION Plus Digital Linear Accelerator,
part number 5857912 equipped with a Digital Electron Variable Applicator (DEVA,
Part Number 8485971) with available energy of 6 MeV, Recall # Z-1760-2008;
i) Siemens Medical Solutions, MEVATRON M2-6740 part number 9401407equipped
with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with
available energy of 6 MeV, Recall # Z-1761-2008;
j) Siemens Medical Solutions, MEVATRON M2-6740 part number 9401506 equipped
with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with
available energy of 6 MeV, Recall # Z-1762-2008;
k) Siemens Medical Solutions, MEVATRON MD-2 part number 9401654 equipped
with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with
available energy of 6 MeV, Recall # Z-1763-2008
CODE
a) Serial numbers: 1938 and 2074;
b) Serial number: 2084;
c) Serial numbers: 2348, 2224, 2431, 2131, and 2405;
d) Serial numbers: 2348 2224 2431 2131, and 2405;
e) Serial numbers:3041 2451 2525 2547 2575 2582 2589 2602 2667 2726 2769 2781
2801 2952, and 2571;
f) Serial numbers: 3061 3986 2469 2476 2443 2455 2549 2719 2728 2772 2795 2821
2925 2999 3056 3083 3088 3169 3282 3325 3429 3432 3472 3538 3555 3563 3593
3633 3637 3682 3685 3726 3971 4007 5055 3923 2707 3321, and 2449;
g) Serial Numbers:3174 3241 3254 2938 3193 3359 3488 3529 3536 3717 3813 3844
3876 3985 3991 4033 4047 2782 2783 2785 2797 2815 2832 2862 2878 2904 2916
2918 2922 2942 2964 2973 2979 2989 2992 2993 2994 3007 3031 3043 3044 3046
3106 3117 3144 3183 3234 3242 3249 3262 3278 3284 3299 3308 3326 3334 3373
3389 3396 3408 3421 3431 3438 3455 3475 3481 3531 3561 3594 3632 3642 3689
3724 3728 3762 3767 3782 3814 3833 3867 3915 4004 4045 4051 4131 4232 5007
3431 3158 3216 3356, and 3619;
h) Serial Number: 3894;
i) Serial number: 2428;
j) Serial Numbers 2355 and 2417;
k) Serial numbers 2205, 2305, 2362, and 2425
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter dated December 12, 2007. Firm initiated recall is ongoing.
REASON
Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
VOLUME OF PRODUCT IN COMMERCE
168 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
X-STOP Interspinous Process Decompression (lPD) System, (With Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK device); Catalog numbers for X-STOP Titanium Implant: 1-2206 US 6MM X-STOP, 1-2208 US 8MM X-STOP, 1-2210 US 10MM X-STOP, 1-2212 US 12MM X-STOP, 1-2214 US 14MM X-STOP. Catalog numbers include for X-STOP PEEK Implant: 1-3206 US 6mm X STOPpk, 1-3208 US 8mm X STOPpk, 1-3210 US 10mm X STOPpk, 1-3212 US 12mm X STOPpk, 1-3214 US 14mm X STOPpk, 1-3216 US 16mm X STOPpk. Spinal implants, Recall # Z-1765-2008
CODE
All units
RECALLING FIRM/MANUFACTURER
Kyphon, Inc., Sunnyvale, CA, by letter and teleconference on January 30, 2008. Firm initiated recall is ongoing.
REASON
Physician instructions revised due to product breakage: During the implantation of the X-STOP IPD Device, the product has the potential to cause damage to and/or breakage of the X-STOP IPD Device's universal wing assembly. This includes the potential for breakage of the wing screw.
VOLUME OF PRODUCT IN COMMERCE
Approximately 25,000 manuals distributed in the US; Internationally – undetermined
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed
by visual color comparison used for the detection of drugs of abuse. Sun Biomedical
Part Number: 15-2016, Recall # Z-1873-2008;
b) VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro
immunoassay test completed by visual color comparison used for the detection of
drugs of abuse. Sun Biomedical Part Number: 15-2017, Recall # Z-1874-2008;
c) VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD);
Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-
BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA);
Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip
(COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC-
OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip (COC-THC-OPI-BZD-
OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Product is intended for in
vitro immunoassay test completed by visual color comparison used for the detection
of drugs of abuse. Sun Biomedical 1) Part 15-2043; 2) Part 15-2046; 3) Part 15-2065;
4) Part 15-2072; 5) Part 15-2080; 6) Part 15-2083; 7) Part 15-2085; 8) Part 15-2095;
and 9) Part 15-2101, Recall # Z-1875-2008
CODE
a) Lot number Vis-OXD-dip 07-018-1-275 or Vis OXD-Dip 07-081-257;
b) Lot number: Vis-PPX Dip 07-094-1-85;
c) 1) Lot: Vis-6SP-Dip 08-021-1; 2) Lot: Vis-6SP-Dip 07-270-1; 3) Lot: Vis-8SP-Dip-
07-207-2; 4) Lot: Vis-9SP-Dip-07-106-1; 5) Lot: Vis-10 Dip 06-204-2, Vis-10 Dip 07-
002-2, Vis-10-Dip-07-231-1; 6) Lot: Vis-10SP-Dip-07-311-1; Vis-10SP-Dip 07-324-1,
VIS 10SP-Dip-08-045-3; 7) Lot: Vis 10SP Dip-07-201-1, Vis-10SP-Dip 07-263-1; 8)
Lot: Vis 5SP-Dip 07-284-2; Vis 5SP-Dip -8-008-01; 9) Lot: Vis-6SP Dip-07-326-1
RECALLING FIRM/MANUFACTURER
Sun Biomedical Laboratories, Inc., Blackwood, NJ, by letters on May 29, 2008. Firm initiated recall is ongoing.
REASON
Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.
VOLUME OF PRODUCT IN COMMERCE
1,137 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis, Recall # Z-2183-2008
CODE
Software version 2.0 and 2.0.1 with Card IQ Module
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated June 11, 2008. Firm initiated recall is ongoing.
REASON
When using any vessel analysis protocol of the AW Suite Card IQ application, the software can reload saved tracking objects (Save State) incorrectly and display an incorrect vessel label over the restored images. This failure only occurs when users create a custom label in the vessel analysis protocol and include leading or trailing blank characters (space bar) in the custom label.
VOLUME OF PRODUCT IN COMMERCE
207 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of Stryker's VERTIER Surgical Table. The tables are AC-powered or air-powered devices intended for use during diagnostic examination or surgical procedures to support the patient, Recall # Z-2189-2008
CODE
Lot/Serial #:070119-24045; 070119-24043; 070202-25062; 070319-27231; 070319-27232; 070202-25058; 071026-39230; 071026-39232; 070216-25279; 071019-38649
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Communications Corp., Flower Mound, TX, by letter dated April 1, 2008.
Manufacturer: Merivaara Corp., Lahti, Finland. Firm initiated recall is ongoing.
REASON
Potential exists for energy chain, which is responsible for protecting hydraulic and electrical cables during up and down motion on VERTIER Surgical Table, to become lodged between column case sections resulting in possible reduction or lose of function to hand and/or foot controls or possible involuntary movement of the table.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
CA, CO, TX and UT
___________________________________
PRODUCT
a) Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter;
Catalog number IP-S5118-N, Recall # Z-2190-2008;
b) Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter;
Catalog number IP-S6118, Recall # Z-2191-2008
CODE
a) Lot number N73127;
b) Lot number N73153
RECALLING FIRM/MANUFACTURER
Cook Vascular, Inc., Vandergrift, PA, by letter dated April 30, 2008. Firm initiated recall is complete.
REASON
Mislabeled - wrong size catheter was packaged in the box.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
Japan and Brazil
___________________________________
PRODUCT
VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a component of the VVsky Vario, BrainSUITE iMRI, BrainSUITE NET and BrainSUITE iCT systems; Intended to be an intraoperative image guided localization system to enable minimally invasive surgery. Indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified to relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy, Recall # Z-2209-2008
CODE
VVsky Art. No. 50945; all VVsky products with Data Billboards and/or microscope integrations and/or Device Connections Panels (Wall Panels)
RECALLING FIRM/MANUFACTURER
Bainlab AG, Kirchheim B. Muenchen, Germany, by letters dated November 12, 2007. Firm initiated recall is ongoing.
REASON
Diameter of cables used for installation are to small for the applied current. If an internal short circuit is produced the medical power supply will not shut down automatically and will continue to deliver current, which could result in overheating cables.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated,
71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is
part of a system used to replace the tibial portion of the knee joint, Recall # Z-2213-
2008;
b) Biomet OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base,
75mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161044. Implant is
part of a system used to replace the tibial portion of the knee joint, Recall # Z-2214-
2008
CODE
a) Lots 053850, Exp 08/2016; 070890, Exp 08/2016; 201930, Exp 09/2016; 364790,
Exp 10/2016; 507290, Exp 11/2016 and 534910, Exp 04/2017;
b) Lots 173950, Exp 09/2016; 188380, Exp 09/2016; 459420, Exp 11/2016; 534920,
Exp 04/2017 and 802650, Exp 12/2016
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated November 7, 2007. Firm initiated recall is complete.
REASON
Mislabeled as to size: Product is labeled as reduced size, but is actually standard size.
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1 each,
Orthopaedic instrument used for the preparation of the implant site prior to device
implantation, Recall # Z-2215-2008;
b) Dynasty Trial Shell 64mm OD, Group H, REF 3300-GH64, Rx only, Non-Sterile,
1 each, Orthopaedic instrument used for the preparation of the implant site prior to
device implantation, Recall # Z-2216-2008;
c) Dynasty Trial Shell 66mm OD, Group H, REF 3300-GH66, Rx only, Non-Sterile,
1 each. Orthopaedic instrument used for the preparation of the implant site prior to
device implantation, Recall # Z-2217-2008;
d) Dynasty Trial Shell 68mm OD, Group H, REF 3300-GH68, Rx only, Non-Sterile,
1 each, Orthopaedic instrument used for the preparation of the implant site prior to
device implantation, Recall # Z-2218-2008
CODE
a) and b) Lot Nos.: 037386983 and 117456822;
c) and d) Lot Nos.: 037386983 and 117459853
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wright Medical Technology Inc., Arlington, TN, by letters on May 20, 2008 and June 4, 2008 and by telephone calls on May 21 and 22, 2008.
Manufacturer: Patterson Machine, Union Grove, AL. Firm initiated recall is ongoing.
REASON
Trials are 2.5 mm larger than marked.
VOLUME OF PRODUCT IN COMMERCE
509 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: B3856,
Size 6F x 24cm Urological stents are disposable single-use temporary indwelling
catheters that allow urine to drain through obstructed or strictured ureters, Recall #
Z-2219-2008;
b) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: B3857,
Size 6F x 26cm Urological stents are disposable single-use temporary indwelling
catheters that allow urine to drain through obstructed or strictured ureters, Recall #
Z-2220-2008;
c) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: B3855,
Size 6F x 22cm Urological stents are disposable single-use temporary indwelling
catheters that allow urine to drain through obstructed or strictured ureters, Recall #
Z-2221-2008;
d) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: B3827,
Size 6F multilength Urological stents are disposable single-use temporary indwelling
catheters that allow urine to drain through obstructed or strictured ureters, Recall #
Z-2222-2008;
e) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: BS123,
Size 6F multilength Urological stents are disposable sing-use temporary indwelling
catheters that allow urine to drain through obstructed or strictured ureters, Recall #
Z-2223-2008;
f) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: B3957,
Size 6F x 26cm Urological stents are disposable single-use temporary indwelling
catheters that allow urine to drain through obstructed or strictured ureters, Recall #
Z-2224-2008
CODE
a) Lot Numbers: 1058016, 1059244 and 1060923;
b) Lot Number: 1059245;
c) Lot Number: 1060602;
d) Lot Number: 1060921;
e) Lot Number: 1060921 and 1062602;
f) Lot Numbers: 1060924 and 1062803
RECALLING FIRM/MANUFACTURER
Applied Medical Resources, Corp., Rancho Santa Margarita, CA, by letter on May 20, 2008. Firm initiated recall is ongoing.
REASON
Possible movement or dislodgement of the positioner marker band during use.
VOLUME OF PRODUCT IN COMMERCE
236 units
DISTRIBUTION
Nationwide, Australia and South Africa
___________________________________
PRODUCT
a) Hamilton Soft Grip Pipettes, 1 ml fixed volume, model number 55019-19 Product is
indicated for manual pipetting, Recall # Z-2232-2008;
b) Hamilton Soft Grip Pipettes, 1 ml adjustable volume, model number 55019-40PRODUCT
is indicated for manual pipetting, Recall # Z-2233-2008
CODE
a) Serial numbers 64133, 64137, 64139, 64145, 64148, 64156, 64163, 64171, 64175, 4180, 64189, 64192, 64193, 64193, 64198, 64199, 64200, 64202, 64203, 64205, 64211, 64212, 64216, 64224, 64225, 64921, 65072, 65081, 65099, 65105, 65107, 65110, 65140, 65141, 65151, 65159, 65160, 65163, 65164, 65172, 65486, 65501, 65517, 65540, 65585, 65599, 65619, 65629, 65658, 65699, 65934, 65951, 65969, 65972, 65992, 66764, 66783, 66788, 66793, 66892, 66897, 66902, 66972, 66982, 66991, 66999, 67001, 67031, 67035, 67044, 67054, 67055, 67059, 67082, 67084, 67091, 67094, 67098, 67120, 67130, 67145, 67162, 67167, 67170, 67175, 67176, 67190, 67191, 67198, 67224, 67237, 67247, 67258, 67260, 67269, 67278, 67280, 67282, 67283, and 67285;

b) Serial numbers 63045, 63098, 63135, 63157, 63208, 63248, 63278, 63378, 63401, 63418, 63421, 63442, 63461, 63485, 63524, 63527, 63590, 63679, 63753, 63788, 63804, 63820, 63825, 63834, 63836, 63848, 63857, 63885, 63892, 63904, 63951, 63989, 63993, 64047, 64057, 64074, 64076, 64093, 64140, 64160, 64242, 64246, 64261, 64279, 64288, 64289, 64314, 64342, 64352, 64362, 64399, 64407, 64427, 64478, 64479, 64480, 64492, 64498, 64504, 64507, 64518, 64520, 64525, 64527, 64528, 64537, 64538, 64543, 64544, 64563, 64577, 64582, 64585, 64587, 64590, 64592, 64599, 64612, 64628, 64631, 64635, 64636, 64644, 64667, 64678, 64694, 64695, 64703, 64706, 64718, 64720, 64722, 64723, 64729, 64740, 64753, , 64757, 64759, 64760, 64763, 64767, 64772, 64778, 64785, 64787, 64789, 64792, 64797, 64801, 64810, 65015, 65016, 65018, 65067, 65068, 65071, 65076, 65078, 65079, 65080, 65083, 65090, 65091, 65109, 65119, 65186, 65204, 65224, 65262, 65269, 65290, 65514, 65536, 65541, 65564, 65566, 65567, 65568, 65575, 65576, 65578, 65583, 65590, 65591, 65597, 65600, 65603, 65608, 65609, 65610, 65612, 65614, 65617, 65622, 65623, 65626, 65628, 65631, 65632, 65635, 65644, 65650, 65655, 65657, 65662, 65678, 65692, 65701, 65705, 65707, 65726, 65747, 65771, 65772, 65773, 65777, 65836, 65858, 65906, 65910, 65916, 65917, 65918, 65921, 65925, 65926, 65927, 65929, 65930, 65933, 65935, 65936, 65938, 65946, 65947, 65952, 65953, 65959, 65961, 65964, 65966, 65973, 65979, 65981, 65982, 65983, 65987, 65993, 65995, 65996, 65997, 65998, 65999, 66000, 66002, 66007, 66008, 66013, 66014, 66015, 66016, 66017, 66019, 66062, 66079, 66088, 66104, 66107, 66115, 66124, 66138, 66145, 66174, 66182, 66196, 66197, 66198, 66201, 66205, 66210, 66222, 66226, 66233, 66252, 66253, 66270, 66286, 66289, 66296, 66305, 66309, 66341, 66342, 66345, 66351, 66353, 66361, 66366, 66372, 66373, 66380, 66397, 66398, 66400, 66402, 66403, 66404, 66417, 66418, 66422, 66423, 66425, 66426, 66431, 66434, 66436, 66438, 66443, 66444, 66448, 66450, 66452, 66453, 66456, 66463, 66465, 66474, 66475, 66480, 66483, 66484, 66488, 66490, 66496, 66497, 66503, 66504, 66505, 66512, 66517, 66519, 66520, 66522, 66523, 66534, 66535, 66538, 66540, 66548, 66549, 66550, 66552, 66555, 66556, 66557, 66558, 66560, 66562, 66565, 66567, 66568, 66569, 66573, 66574, 66576, 66577, 66578, 66582, 66584, 66591, 66601, 66603, 66605, 66607, and 66612
RECALLING FIRM/MANUFACTURER
Hamilton Co., Reno, NV, by letter on May 7, 2008. Firm initiated recall is ongoing.
REASON
Manufacturing issue with spring may restrict product to drawing less than ½ of its stated measured capacity.
VOLUME OF PRODUCT IN COMMERCE
353 units
DISTRIBUTION
Nationwide, PR, New Zealand, Australia, Japan and Canada
___________________________________
PRODUCT
NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle, Recall # Z-2235-2008
CODE
Serial numbers 400562, 400563, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, and NDH034EI
RECALLING FIRM/MANUFACTURER
Philips and Neusoft Medical Systems, Co., Ltd., Liaoning, China, by letter dated December 13, 2007. Firm initiated recall is complete.
REASON
Labeling of patient position on scanned image does not match actual patient orientation.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CO, FL, KY, NC, SC, TN and TX
___________________________________
PRODUCT
1) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-
15242, Intended for single use only, Sterile, Rx only. The product is used for long
term hemodialysis vascular access, Recall # Z-2242-2008;
2) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-
15282, Intended for single use only, Sterile, Rx only. The product is used for long
term hemodialysis vascular access, Recall # Z-2243-2008;
3) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-
15322, Intended for single use only, Sterile, Rx only. The product is used for long
term hemodialysis vascular access, Recall # Z-2244-2008;
4) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-
15362, Intended for single use only, Sterile, Rx only. The product is used for long
term hemodialysis vascular access, Recall # Z-2245-2008;
5) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-
15552, Intended for single use only, Sterile, Rx only. The product is used for long
term hemodialysis vascular access, Recall # Z-2246-2008;
6) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CSD-
15242, Intended for single use only, Sterile, Rx only. The product is used for long
term hemodialysis vascular access, Recall # Z-2247-2008;
7) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CSD-
15282, Intended for single use only, Sterile, Rx only. The product is used for long
term hemodialysis vascular access, Recall # Z-2248-2008;
8) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CSD-
15322, Intended for single use only, Sterile, Rx only. The product is used for long
term hemodialysis vascular access, Recall # Z-2249-2008;
9) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CSD-
15362, Intended for single use only, Sterile, Rx only, The product is used for long
term hemodialysis vascular access, Recall # Z-2250-2008;
10) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CSD-
15552, Intended for single use only, Sterile, Rx only. The product is used for long
term hemodialysis vascular access, Recall # Z-2251-2008;
11) Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-
15242-SP, Intended for single use only, Sterile, Rx only. The product is used for
long term hemodialysis vascular access, Recall # Z-2252-2008;
12) Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-
15282-SP, Intended for single use only, Sterile, Rx only. The product is used for
long term hemodialysis vascular access, Recall # Z-2253-2008;
13) Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-
15322-SP, Intended for single use only, Sterile, Rx only. The product is used for
long term hemodialysis vascular access, Recall # Z-2254-2008;
14) Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-
15362-SP, Intended for single use only, Sterile, Rx only. The product is used for
long term hemodialysis vascular access, Recall # Z-2255-2008;
15) Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-
15552-SP, Intended for single use only, Sterile, Rx only. Road, The product is
used for long term hemodialysis vascular access, Recall # Z-2256-2008;
16) Cannon® II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-
15242-VSP, Intended for single use only, Sterile, Rx only. The product is used for
long term hemodialysis vascular access, Recall # Z-2257-2008;
17) Cannon® II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-
15282-VSP, Intended for single use only, Sterile, Rx only. The product is used for
long term hemodialysis vascular access, Recall # Z-2258-2008;
18) Cannon® II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-
15322-VSP, Intended for single use only, Sterile, Rx only. The product is used for
long term hemodialysis vascular access, Recall # Z-2259-2008;
19) Cannon® II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-
15362-VSP, Intended for single use only, Sterile, Rx only. The product is used for
long term hemodialysis vascular access, Recall # Z-2260-2008;
20) Cannon® II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-
15552-VSP, Intended for single use only, Sterile, Rx only. The product is used for
long term hemodialysis vascular access, Recall # Z-2261-2008;
21) Cannon® II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter
Length, Cuff to Tip: 19cm, CSD-15242-SP, Intended for single use only, Sterile,
Rx only. The product is used for long term hemodialysis vascular access, Recall #
Z-2262-2008;
22) Cannon® II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter
Length, Cuff to Tip: 23cm, CSD-15282-SP, Intended for single use only, Sterile,
Rx only. The product is used for long term hemodialysis vascular access, Recall #
Z-2263-2008;
23) Cannon® II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter
Length, Cuff to Tip: 27cm, CSD-15322-SP, Intended for single use only, Sterile,
Z-2264-2008;
24) Cannon® II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter
Length, Cuff to Tip: 31cm, CSD-15362-SP, Intended for single use only, Sterile,
Rx only. The product is used for long term hemodialysis vascular access, Recall #
Z-2265-2008;
25) Cannon® II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter
Length, Cuff to Tip: 50cm, CSD-15552-SP, Intended for single use only, Sterile,
Rx only. The product is used for long term hemodialysis vascular access, Recall #
Z-2266-2008;
26) Cannon® II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-
Term Access, Cuff to Tip: 19cm, CS-15242-SPM, Intended for single use only,
Sterile, Rx only. The product is used for long term hemodialysis vascular access,
Recall # Z-2267-2008;
27) Cannon® II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-
Term Access, Cuff to Tip: 23cm, CS-15282-SPM, Intended for single use only,
Sterile, Rx only. The product is used for long term hemodialysis vascular access,
Recall # Z-2268-2008;
28) Cannon® II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-
Term Access, Cuff to Tip: 27cm, CS-15322-SPM, Intended for single use only,
Sterile, Rx only. The product is used for long term hemodialysis vascular access,
Recall # Z-2269-2008;
29) Cannon® II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-
Term Access, Cuff to Tip: 31cm, CS-15362-SPM, Intended for single use only,
Sterile, Rx only. The product is used for long term hemodialysis vascular access,
Recall # Z-2270-2008;
30) ARROW Edge® Hemodialysis Catherization Set with Arrow Simplicity", Long-
Term Access, Cuff to Tip: 19cm, CS-15242-IM, Intended for single use only,
Sterile, Rx only. The product is used for long term hemodialysis vascular access,
Recall # Z-2271-2008;
31) ARROW Edge® Hemodialysis Catherization Set with Arrow Simplicity", Long-
Term Access, Cuff to Tip: 23cm, CS-15282-IM, Intended for single use only,
Sterile, Rx only. The product is used for long term hemodialysis vascular access,
Recall # Z-2272-2008;
32) ARROW Edge® Hemodialysis Catherization Set with Arrow Simplicity", Long-
Term Access, Cuff to Tip: 27cm, CS-15322-IM, Intended for single use only,
Sterile, Rx only. The product is used for long term hemodialysis vascular access,
Recall # Z-2273-2008;
33) ARROW Edge® Hemodialysis Catherization Set with Arrow Simplicity", Long-
Term Access, Cuff to Tip: 31cm, CS-15362-IM, Intended for single use only,
Sterile, Rx only. The product is used for long term hemodialysis vascular access,
Recall # Z-2274-2008;
34) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip:
31cm, ASK-15362-I, Intended for single use only, Sterile, Rx only. The product is
used for long term hemodialysis vascular access, Recall # Z-2275-2008;
35) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip:
19cm, CS-15242-I, Intended for single use only, Sterile, Rx only. The product is
used for long term hemodialysis vascular access, Recall # Z-2276-2008;
36) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip:
23cm, CS-15282-I, Intended for single use only, Sterile, Rx only. The product is
used for long term hemodialysis vascular access, Recall # Z-2277-2008;
37) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip:
27cm, CS-15322-I, Intended for single use only, Sterile, Rx only. The product is
used for long term hemodialysis vascular access, Recall # Z-2278-2008;
38) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Catheter
Length, Cuff to Tip: 31cm, CS-15362-I, Intended for single use only, Sterile, Rx
only. The product is used for long term hemodialysis vascular access, Recall #
Z-2279-2008;
39) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Catheter
Length, Cuff to Tip: 50cm, CS-15552-I, Intended for single use only, Sterile, Rx
only. The product is used for long term hemodialysis vascular access, Recall #
Z-2280-2008;
40) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip:
19cm, CSD-15242-I, Intended for single use only, Sterile, Rx only. The product is
used for long term hemodialysis vascular access, Recall # Z-2281-2008;
41) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip:
23cm, CSD-15282-I, Intended for single use only, Sterile, Rx only. The product is
used for long term hemodialysis vascular access, Recall # Z-2282-2008;
42) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip:
27cm, CSD-15322-I, Intended for single use only, Sterile, Rx only. The product is
used for long term hemodialysis vascular access, Recall # Z-2283-2008;
43) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Catheter
Length, Cuff to Tip: 31cm, CSD-15362-I, Intended for single use only, Sterile, Rx
only. The product is used for long term hemodialysis vascular access, Recall #
Z-2284-2008;
44) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Catheter
Length, Cuff to Tip: 50cm, CSD-15552-I, Intended for single use only, Sterile, Rx
only. The product is used for long term hemodialysis vascular access, Recall #
Z-2285-2008
CODE
1) Lot #RL7065076, RL7054704, RL7034338, RL6123772, RL6113608, RL6103456,
and RL6062695;
2) Lot#RL7054799, RL7044546, RL044529, RL7034289, RL7024171, RL7013848,
RL6123738, RL6113609, RL6083023, RL6072946, and RL6062692;
3) Lot#RL7075217, RL7034341, RL7013847, RL6113498, and RL6093309;
4) Lot# RL8016430, RL7105756, RL7085366, RL7034449, RL7034288, and
RL7013906;
5) Lot# RL6093219;
6) Lot# RL6022012, RL5111395, RF5061635, and RF5072839;
7) Lot# RL5111237, RL5111325, and RF5061636;
8) Lot # RL5111238, RL5111377, and RF5072840;
9) Lot # RL5121655;
10) Lot # RR6032277, RL5111326, and RF5061637;
11) Lot # RL7075215, RL7064985, RL7064903, RL7054802, RL7054705, RL7044578,
RL7034399, RL7034286, RL7034261, RL7013996, RL7013949, RL7013902,
RL6123700, RL6113625, RL6113607, RL6113514, RL6103459, RL6103393,
RL6093277, RL6093222, RL6083018, RL6082997, RL6072898, RL6072876,
RL6072850, TL6062700, RL6052656, RL6052609, RL6052575, RL6042517,
RL6032357, RL6032272, RL6022005, RL6011963, RL6011844, RL6011793,
RL5121650, RL5121602, RL5090953, RL5080571, RF5072292, RF5061640,
RF5060898, RF65060780, and RF5060301;
12) Lot # RL7075150, RL7064986, RL7064906, RL7054803, RL7054788, RL7054736,
RL7054683, RL7044663, RL7044624, RL7044585, RL7044550, RL7044523,
RL7034284, RL7034260, RL7024169, RL7024104, RL7024055, RL7014000,
RL7013948, RL7013904, RL6123775, RL6113626, RL6113515, RL6103458,
RL6103395, RL6103338, RL6093225, RL6083143, RL6083140, RL6083094,
RL6083071, RL6083016, RL6082995, RL6082973, RL6072909, RL6072864,
RL6072851, RL6052657, RL6052642, RL6052610, RL6052576, RL6042518,
RL6042442, RL6032353, RL6032273, RL6022085, RL6022007, RL6011823,
RL6011738, RL5121604, RL5111324, RL5101066, RL5090954, RL5090813,
RR5080673, RF5072293, RF5061641, RF5060901, RF5060302, RF5054487,
RF50546780, and RF5055030;
13) Lot # RL7116004, RL7065080, RL7054804, RL705735, Lot# RL7054676,
Rl7044642, RL7044580, Rl7044502, RL7034343, RL7034263, RL7024056,
RL7013999, RL7013950, RL6123778, RL6113627, RL6113599, RL6113492,
RL6103457, RL6103394, RL6093276, RL6093220, RL6083122, RL6083020,
RL6072902, RL60172877, RL6062701, RL6052658, RL6052611, RL6052604,
RL6052577, RL6042447, RL6042443, RL6032355, RL6021983, RL6011962,
RL6011956, RL6011794, RL6011735, RL5121426, RL5111374, RL5101070,
RL5090955, RL5090812, RF5072294, RF5061642, and RF5060483;
14) Lot # RL7054708, RL7044581, RL7034346, RL7034265, RL7024126,
RL7013907, RL6123780, RL6113628, RL6103472, RL6083021, RL6082998,
RL6072905, RL6072878, RL6062702, RL6052612, RL6042519, RL6032356,
RL6022010, RL6011957, RL6011824, RL5121652, RL5111412, RL5101060,
RL5090814, RF5084114, and RR5060807;
15) Lot # RL7075218, RL7064990, RL7064908, RL7054830, RL7044582,
RL7034349, RL7034266, RL7024127, RL6123781, RL6113600, RL6103473,
RL6103401, RL6103364, RL6083123, RL6083003, RL6072883, RL6062744,
RL6052634, RL6052555, RL6042448, RL6032275, RL6022011, RL6011847,
RL6011825, RL6011739, RL5121605, RL5121428, RL5111376, RL5090815,
RF5072295, and RF5061643;
16) Lot #RL7075165, RL7064971, RL7044662, RL7034337, RL703420, RL7024049,
RL7013953, RL6103343, RL6062812, and RL6062755;
17) Lot # RL7085440, RL7085404, RL7075211, RL7064954, RL7044506,
RL7024090, RL7013829, RL6103375, RL6062769, and RL6062726;
18) Lot # RL7095627, RL7095600, RL7085439, RL7075264, RL7075167, RL7065039,
RL7034322, RL7024125, RL7013825, RL6103336, RL6062767, and RL6062747;
19) Lot # RL7095524, RL7075134, RL7065041, RL7054792, RL7034390, RL7013965,
RL6062819, and RL6062756;
20) Lot # RL7075168, RL7054790, RL7024123, RL6093201, RL6083117, and
RL6062757;
21) Lot # RL7065083, RL7064902, RL7054801, RL7024113, RL6103474, RL6093296,
RL6083017, RL6082996, RL6062685, RL5101072, and RL5090957;
22) Lot # RL7085368, RL7075149, RL7044668, RL7034447, RL7013872, RL6113551,
RL6103403, RL6082978, and RL5090961;
23) Lot # RL7034372, RL6093298, RL6083063, RL6072900, and RL5090966;
24) Lot # RL7044504, RL7013995, RL6103475, RL6093299, RL6072906, and
RL5111239;
25) Lot # RL7054829, RL6113552, RL6083022, RL6072884, and RL5101077;
26) Lot # RL7075164, RL7064972, RL7044661, RL7034319, RL7013952, RL6123683,
RL6113590, RL6103342, RL6103321, RL6082972, RL6062811, RL6052578,
RL6032233, RL6022006, RL5111401, RL5111314, RL5111273, RL5090749,
RF5071974, and RF5060633;
27) Lot # RL7095520, RL7085441, RL7085403, RL7075210, RL7065038, RL7054747,
RL7044505, RL7034336, RL7034318, RR7013954, RL7013828, RL6123684,
RL6113591, RL6103374, RL6072853, RL6062768, RL6052527, RL6032350,
RL6022008, RL6011846, RL6011741, RL5121549, RL5111399, RL5101067,
RL5090754, RF5083471, RF5072252, RF5060634, RF5055030, and RF5054823;
28) Lot # RL7095626, RL7085438, RL7075166, RL7065040, RL7034321,
RL7024124, RL7013824, RL6123697, RL6103335, RL6083070, RL6082980,
RL6062766, RL6022021, RL5121547, RL5111400, RL5111259, RF5083830,
RF5072253, and RF5060635;
29) Lot # RL7095523, RL7075133, RL7054791, RL7034389, RL7013964,
RL6123685, RL6083038, RL6082970, RL6062818, RL6032303, RL5121548,
RL5111402, RL5111274, RL5090726, RF5083831, and RF5060632;
30) Lot # RL7085497, RL7075135, RL7024105, RL7024062, RL7013817,
RL6103430, RL6083098, RL6083036, RL6062788, RL6052633, RL6022022,
RL6021973, RL5090950, and RR5051996;
31) Lot # RL7075140, RL7065024, RL7054781, RL7034393, RL7024052, RL7013831,
RL6123782, RL6103334, RL6083092, RL6072882, RL6062813, RL6062783,
RL6052613, RL6042444, RL6022023, RL6011960, RL5090951, and RF5054861;
32) Lot #RL7075138, RL7065026, RL7034395, RL7024054, RL7013963, RL6113593,
RL6062816, RL6062772, RR5101171, RL5101008, and RF5054862;
33) Lot# RL7034396, RL6113592, RL6103341, RL6062790, RL5101009, and
R5051995;
34) Lot #8016512;
35) Lot # RL7075136, RL7034391, RL6083099, RL6083037, RL6062789, RL6011934,
RL5121649, RL5111321, RR5101165, RF5084348, and RF5072121;
36) Lot # RL7075139, RL7065023, RL7054780, RL7034392, RL7024053, RL7013830,
RL6123783, RL610333, RL6083093, RL6072881, RL6062814, RL6062784,
RR5101166, RL5090831, and RL5090775;
37) Lot # RL7075137, RL7065025, RL7054779, RL7034394, RL6113594,
RL6083058, RL5121614, RR5101169, RL5090832, RL5090780, and RF505455;
38) Lot # RL7013940, RL6062791, RR5101168, RL5090833, and RL5090776;
39) Lot # RL7034397, RL7013939, RL6062815, RL6062792, RL5121654,
RL5090834, RL5080628, and RF5060906;
40) Lot# RL7065082, RL6093295, and RL6082990;
41) Lot # RL7075214, RL6103402, and RL6083025;
42) Lot # RL6123742, RL6083061, and RL6082992;
43) Lot # RL7064991,and RL6083027;
44) Lot # RL7065084, and RL6093204
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Reading, PA, by letter on/about June 10, 2008.
Manufacturer: Arrow International Inc., Asheboro, NC. Firm Initiated recall is ongoing.
REASON
The tips may not have been adequately welded to the catheter body.
VOLUME OF PRODUCT IN COMMERCE
79,248 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Piccolo Chemistry Analyzer software version 6.121. Model Number 400-1028 in
polyfoil pouch. Piccolo Comprehensive Metabolic Panel is a single-use self-
contained reagent disk, intended for use with the Piccolo and PiccoloXpress
chemistry analyzers, for in vitro qualitative determination., Recall # Z-2286-2008;
b) Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel, model
number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a single-use, self-
contained reagent disk intended for use with the Piccolo and PiccoloXpress chemistry
analyzers, for in vitro qualitative determination, Recall # Z-2287-2008
CODE
a) Lot # 8111AA5, exp. date 2009-03-10;
b) Lot # 8041AC5, exp. date 2009-01-21
RECALLING FIRM/MANUFACTURER
Abaxis, Inc., Union City, CA, by letter on April 21, 2008. Firm initiated recall is ongoing.
REASON
The product will recover tCO2 at approximately 5-7 units high relative to 03-10.
VOLUME OF PRODUCT IN COMMERCE
1,130 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Stryker Navigation Pin for use with the Stryker Navigation System, 3 mm x 100 mm;
Part 6007-003-100. Stryker Navigation Pin for use with the Stryker navigation
system is used for trauma and orthopedic applications, e.g. hip and knee modules,
Recall # Z-2288-2008;
b) Stryker Navigation Pin for use with the Stryker Navigation System, 3 mm x 150 mm;
Part 6007-003-150. Stryker Navigation Pin for use with the Stryker Navigation
System is used for trauma and orthopedic applications, e.g. hip and knee modules,
Recall # Z-2289-2008;
c) Stryker Navigation Pin for use with the Stryker Navigation System, 4 mm x 100 mm;
Part 6007-004-100. Stryker Navigation Pin for use with the Stryker Navigation
System is used for trauma and orthopedic applications, e.g. hip and knee modules,
Recall # Z-2290-2008;
d) Stryker Navigation Pin for use with the Stryker Navigation System, 4 mm x 150 mm;
Part 6007-004-150. Stryker Navigation Pin for use with the Stryker Navigation
System is used for trauma and orthopedic applications, e.g. hip and knee modules,
Recall # Z-2291-2008;
e) Stryker Ortholock EX Pin for use with the Stryker Navigation System, 3 mm x 110
mm; Part 6007-103-110. Stryker Navigation Pin for use with the Stryker Navigation
System is used for trauma and orthopedic applications, e.g. hip and knee modules,
Recall # Z-2292-2008;
f) Stryker Ortholock EX Pin for use with the Stryker Navigation System, 4 mm x 150
Mm; Part 6007-104-150. Stryker Navigation Pin for use with the Stryker Navigation
System is used for trauma and orthopedic applications, e.g. hip and knee modules,
Recall # Z-2293-2008;
g) Stryker Ortholock; Part 6007-003-000. Stryker Ortholock is used to firmly anchor a
tracker intended for patient tracking during computer aided orthopaedic and trauma
applications, Recall # Z-2294-2008
CODE
All units distributed prior to 6/5/08.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments, Div. of Stryker Corp., Portage, MI, by letter dated June 5, 2008.
Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON
Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
VOLUME OF PRODUCT IN COMMERCE
28,861 boxes
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Miller bone cement injector front loading cartridge kit, compatible with Zimmer vacuum mixing system, QTY - 10, sterile; Cat. No. 5069-52. The product is used for the injection of bone cement, Recall # Z-2295-2008
CODE
Lot # 60750536
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated June 30, 2008
Manufacturer: Zimmer Orthopaedic Surgical Products, Dover, OH. Firm initiated recall is ongoing.
REASON
The cartridge is brittle and at increased risk of breakage.
VOLUME OF PRODUCT IN COMMERCE
257 packages of 10 kits each
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Zimmer Patient Helper Reinforced Overhead Bar for Hill-Rom beds with removable
headboards; Prod. Nos. 00-0965-000-00 and 00-0965-001-00. The product is an L
shaped bar that is used with hospital beds set up for traction. The bar allows mounting
of a trapeze to help the patient pull themselves up when in the hospital bed, Recall #
Z-2296-2008;
b) Zimmer Patient Helper Reinforce Overhead Bar for Hill-Rom Versa Care beds; The
product is a L shaped bar that is used with hospital beds set up for traction. The bar
allows mounting of a trapeze to help the patient pull themselves up when in the
hospital bed; Prod. Nos. 00-2700-965-02 and 00-0965-001-00, Recall # Z-2297-2008;
c) Zimmer Freestanding Patient Helper for Hill-Rom Totalcare beds; Prod. Nos. 00-
2700-965-00 and 00-0965-001-00. The product is a L shaped bar that is used with
hospital beds set up for traction. The bar allows mounting of a trapeze to help the
patient pull themselves up when in the hospital bed, Recall # Z-2298-2008
CODE
All units shipped between 7/11/07 and 5/19/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated July 7, 2008
Manufacturer: Zimmer Orthopaedic Surgical Products, Dover, OH. Firm initiated recall is ongoing.
REASON
If the bed is in the upright position and the bar is dropped rapidly or in free-fall, it could strike the patient in the bed, and the drop could present a laceration hazard by creating a sharp edge on the metal bar.
VOLUME OF PRODUCT IN COMMERCE
645 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
NeuViz Dual series computed Tomography Scanner System, X-Ray System, Recall # Z-2307-2008
CODE
Serial numbers: 400562, 400563, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, and NDH034EI
RECALLING FIRM/MANUFACTURER
Philips And Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning  
China, by letter dated June 10, 2008. Firm initiated recall is ongoing.
REASON
Potential for R-host box and components inside to be detached of its mounting during the gantry rotor rotation. There is a potential for components to be damaged inside the system gantry and for the internal components to be expelled from the system gantry and injure the patient, operator, bystander or service people.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
NC, CO, FL, KY, SC, TN and TX
___________________________________
PRODUCT
Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy treatments, Recall # Z-2308-2008
CODE
H480001 H480341 H480738 H481107 H481548 H482157 H482608 H483158 H483809 H484524 H480003 H480345 H480740 H481108 H481553 H482158 H482609 H483159 H483818 H484535 H480004 H480348 H480749 H481114 H481554 H482159 H482611 H483161 H483820 H484539 H480009 H480351 H480753 H481115 H481556 H482160 H482624 H483164 H483821 H484540 H480012 H480355 H480754 H481116 H481558 H482162 H482625 H483180 H483823 H484544 H480017 H480356 H480756 H481133 H481559 H482163 H482630 H483181 H483830 H484553 H480019 H480357 H480762 H481135 H481567 H482166 H482634 H483191 H483835 H484603 H480022 H480358 H480764 H481141 H481571 H482173 H482638 H483207 H483840 H484610 H480025 H480367 H480766 H481142 H481572 H482178 H482641 H483224 H483843 H484617 H480026 H480371 H480773 H481143 H481573 H482179 H482645 H483244 H483847 H484634 H480030 H480373 H480775 H481163 H481585 H482189 H482648 H483253 H483852 H484639 H480032 H480375 H480776 H481180 H481588 H482198 H482662 H483254 H483858 H484640 H480040 H480382 H480779 H481195 H481597 H482199 H482664 H483255 H483869 H484641 H480042 H480385 H480781 H481196 H481599 H482203 H482671 H483270 H483915 H484643 H480043 H480404 H480794 H481197 H481601 H482204 H482681 H483275 H483916 H484650 H480049 H480411 H480798 H481198 H481602 H482205 H482683 H483277 H483942 H484657 H480050 H480416 H480810 H481205 H481605 H482215 H482691 H483312 H483943 H484658 H480056 H480417 H480814 H481206 H481607 H482225 H482697 H483315 H483970 H484673 H480063 H480418 H480816 H481213 H481609 H482228 H482698 H483317 H483973 H484677 H480067 H480420 H480817 H481226 H481618 H482243 H482704 H483322 H483975 H484680 H480068 H480421 H480820 H481229 H481625 H482244 H482709 H483325 H483984 H484681 H480072 H480432 H480821 H481232 H481627 H482247 H482714 H483328 H483987 H484684 H480073 H480443 H480827 H481239 H481631 H482256 H482715 H483341 H483988 H484695 H480075 H480445 H480830 H481250 H481632 H482264 H482726 H483345 H483991 H484698 H480078 H480455 H480833 H481252 H481641 H482273 H482762 H483355 H483994 H484699 H480095 H480458 H480839 H481257 H481647 H482274 H482763 H483356 H484002 H484706 H480102 H480459 H480852 H481259 H481661 H482283 H482770 H483363 H484003 H484744 H480104 H480461 H480855 H481262 H481678R1 H482284 H482773 H483370 H484010 H484752 H480105 H480462 H480861 H481279 H481681 H482285 H482791 H483371 H484015 H484757 H480108 H480464 H480868 H481285 H481692 H482286 H482796 H483373 H484024 H484770 H480109 H480470 H480873 H481286 H481696 H482288 H482799 H483381 H484031 H484781 H480116 H480478 H480876 H481289 H481698 H482292 H482801 H483384 H484049 H484788 H480117 H480483 H480886 H481294 H481702 H482295 H482803 H483396 H484052 H484839 H480123 H480485 H480891 H481297 H481711 H482327 H482815 H483410 H484053 H484844 H480128 H480486 H480893 H481299 H481715 H482369 H482817 H483424 H484057 H484846 H480129 H480488 H480894 H481312 H481716 H482372 H482818 H483427 H484077 H484856 H480131 H480496 H480896 H481315 H481717 H482374 H482824 H483431 H484083 H484861 H480138 H480500 H480897 H481318 H481718 H482380 H482826 H483434 H484085 H484864 H480140 H480510 H480906 H481319 H481724 H482381 H482832 H483449 H484087 H484873 H480141 H480513 H480907 H481326 H481727 H482389 H482835 H483453 H484099 H484910 H480142 H480530 H480908 H481330 H481748 H482390 H482842 H483459 H484105 H484911 H480151 H480533 H480916 H481334 H481751 H482401 H482844 H483463 H484121 H484912 H480152 H480535 H480923 H481338 H481754 H482403 H482849 H483465 H484124 H484960 H480172 H480536 H480927 H481340 H481758 H482408 H482853 H483466 H484128 H485041 H480174 H480537 H480930 H481341 H481765 H482411 H482856 H483477 H484135 H485053 H480183 H480539 H480933 H481344 H481767 H482418 H482865 H483495 H484144 H485079 H480185 H480542 H480937 H481345 H481768 H482420 H482870 H483496 H484149 H485083 H480186 H480543 H480945 H481352 H481770 H482436 H482871 H483500 H484155 H485113 H480190 H480547 H480946M H481357 H481771 H482438 H482876 H483506 H484160 H485114 H480199 H480549 H480946R1 H481358 H481791 H482439 H482882 H483509 H484161 H485135 H480200 H480554 H480951 H481361 H481797 H482440 H482888 H483525 H484163 H485183 H480201 H480573 H480953 H481364 H481800 H482442 H482890 H483531 H484170 H485188 H480207 H480577 H480958 H481374 H481802 H482448 H482897 H483532 H484174 H485209 H480211 H480587 H480961 H481376 H481803 H482450 H482915 H483535 H484175 H485219 H480212 H480588 H480963 H481377 H481810 H482456 H482921 H483538 H484177 H485268 H480217 H480589 H480964 H481378 H481818 H482460 H482926 H483555 H484180 H485269 H480219 H480596 H480967 H481384 H481824 H482461 H482928 H483557 H484185 H485271 H480220 H480599 H480968 H481389 H481825 H482473 H482941 H483558 H484221 H485276 H480222 H480601 H480970 H481391 H481834 H482484 H482946 H483587 H484228 H485279 H480233 H480606 H480971 H481393 H481837 H482485 H482964 H483591 H484254 H485288 H480238 H480608 H480973 H481401 H481840 H482487 H482982 H483592 H484257 H485311 H480239 H480611 H480974 H481406 H481849 H482489 H482988 H483595 H484258 H485333 H480244 H480615 H480976M H481420 H481857 H482492 H482989 H483602 H484269 H485365 H480245 H480617 H480976R1 H481421 H481859 H482493 H482992 H483606 H484274 H485371 H480247 H480619 H480983 H481423 H481861 H482502 H482993 H483615 H484277 H485389 H480248 H480622 H480985 H481426 H481862 H482506 H483001 H483616 H484280 H485399 H480250 H480626 H480989 H481429 H481880 H482508 H483002 H483619 H484286 H485430 H480265 H480639 H480992 H481431 H481881 H482519 H483010 H483632 H484287 H485453 H480266 H480645 H480993 H481432 H481892 H482520 H483012 H483639 H484321 H485457 H480278 H480651 H480994 H481435 H481893 H482521 H483024 H483646 H484324 H485471 H480281 H480653 H481006 H481436 H481896 H482522 H483028 H483647 H484333 H485520 H480283 H480657 H481011 H481442 H481897 H482531 H483029 H483650 H484337 H485547 H480286 H480658 H481014 H481446 H481900 H482539 H483040 H483654 H484340 H485558 H480289 H480659 H481022 H481448 H481901 H482540 H483042 H483670 H484347 H485569 H480295 H480661 H481041 H481467 H481910 H482544 H483057 H483675 H484348 H485592 H480301 H480662 H481043 H481475 H481911 H482545 H483063 H483679 H484351 H485596 H480305 H480671 H481054 H481486 H481918 H482556 H483088 H483686 H484367 H485628 H480307 H480691 H481058 H481487 H481921 H482561 H483091 H483688 H484371 H485658 H480309 H480692 H481060 H481489 H481927 H482562 H483095 H483690 H484374 H485684 H480311 H480694 H481062 H481493 H481936 H482564 H483103 H483691 H484375 H485692 H480316 H480698 H481063 H481494 H481939 H482566 H483106 H483697 H484383 H485693 H480319 H480702 H481066 H481503 H481940 H482571 H483115 H483706 H484386 H485695 H480321 H480704 H481070 H481504 H481952 H482572 H483117 H483717 H484388 H485696 H480323 H480714 H481071 H481507 H482114 H482578 H483123 H483749 H484421 H485719 H480329 H480717 H481074 H481513 H482120 H482586 H483134 H483750 H484437 H485721 H480333 H480718 H481077 H481515 H482121 H482587 H483138 H483751 H484467 H485846 H480336 H480722 H481079 H481526 H482124 H482590 H483143 H483755 H484476 H485853 H480340M H480726 H481088 H481530 H482125 H482593 H483151 H483757 H484497 H485943 H480340R1 H480727 H481104 H481535 H482129 H482594 H483153 H483767 H484509 H485995 H480732 H481106 H481544 H482151 H482603 H483154 H483803 H484513 H486114 H486135 H486209 H486214 H486250 H486403 H486434 H486657 and H486313
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on June 11, 2008. Firm initiated recall is ongoing.
REASON
Software anomaly in which swapping IDs of planning fields can produce inconsistencies between dose matrix and field parameters.
VOLUME OF PRODUCT IN COMMERCE
907 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases, Recall # Z-2329-2008
CODE
Versions 3.17 and 4.1
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, software corrections were sent as of October 30, 2003 to clients. Firm initiated recall is complete.
REASON
Loss of text misrepresented individual tissue diagnosis on the final diagnosis print out from the HIS system software. The specimen heading "J" was removed and the diagnosis appeared under the specimen heading "I" as a result the specimen with the heading "I" had two diagnosis.
VOLUME OF PRODUCT IN COMMERCE
335 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device is used to access vertebral body during balloon kyphoplasty, a procedure designed to reduce and stabilize vertebral body compression fractures (VCFS), Recall # Z-2347-2008
CODE
Lot: J8052810
RECALLING FIRM/MANUFACTURER
Kyphon Inc., Sunnyvale, CA, by letter on June 23, 2008. Firm initiated recall is ongoing.
REASON
Some products may contain the incorrect introducer stylet. If the treating physician is unfamiliar with the use and design of the diamond tip stylet, there is a possibility of serious injuring occurring with the use of the diamond tip stylet during balloon kyphoplasty procedure. Other risks include delay to surgery and inconvenience to patient.
VOLUME OF PRODUCT IN COMMERCE
310 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems, Recall # Z-2348-2008
CODE
Serial numbers: 07-001 through 07-030
RECALLING FIRM/MANUFACTURER
Acacia Engineered Products LLC, Franklin, TN, by letter on July 9, 2008 and by telephone. Firm initiated recall is ongoing.
REASON
The firm distributed an unapproved medical device.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013 and 3023. Products are designed for efficient sterilization of non-porous and porous, heat and moisture-stable materials used in healthcare facilities, Recall # Z-2350-2008
CODE
Model numbers only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp, Mentor, OH, by telephone beginning on March 6, 2008.
Manufacturer: Steris Mexico, Guadalupe, Mexico. Firm initiated recall is ongoing.
REASON
Some Eagle 3000 units may have a door post pin missing which could cause incomplete or no engagement of the radial arms into the lock rails of the door. The sterilizer is designed with switches that prevent cycle initiation if the door is not locked. However, in the event the door switches are not properly adjusted they may falsely indicate that the door is locked even though the radial arms may not be fully engaged correctly. Risks associated with this problem include burns from escaping steam or injury from the door failure.
VOLUME OF PRODUCT IN COMMERCE
148 units
DISTRIBUTION
Nationwide, Canada and Mexico
___________________________________
PRODUCT
InterGro DBM Demineralized Bone Matrix in a lipid carrier; REF DBM002. InterGro DBM product contain human tissue (allograft bpm) and are intended for transplantation. Products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure, Recall # Z-2351-2008
CODE
Lots 259990 and 318630 (exp 07/2009).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Orthopaedic Products, Inc., Grandville, MI, by visit on or about May 5, 2008.
Manufacturer: EBI, LP, Parsippany NJ. Firm initiated recall is complete.
REASON
Exposure to temperature extremes -- Product was not stored under controlled conditions and may have been temperature abused. Exposure to temperature extremes could cause problems with device safety (e.g. risk of infection) or problems with device effectiveness (e.g. lower healing rates if the factors or collagen in the device were affected by the temperature extremes).
VOLUME OF PRODUCT IN COMMERCE
4 packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label]
H74917511, Catalog # 1751, Material No. [Inner Pouch Label] H74917510.
Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed
to provide torsional control. The guidewire has a shapeable and highly radiopaque
distal platinum tip, Recall # Z-2362-2008;
b) Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label]
H74917521, Catalog # 1752, Material No. [Inner Pouch Label] H74917520. Sterilized
with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide
torsional control. The guidewire has a shapeable and highly radiopaque distal platinum
tip, Recall # Z-2363-2008;
c) Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label]
H74917531, Catalog # 1753, Material No. [Inner Pouch Label] H74917530. Sterilized
with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide
torsional control. The guidewire has a shapeable and highly radiopaque distal platinum
tip, Recall # Z-2364-2008;
d) Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label]
H74917541, Catalog # 1754, Material No. [Inner Pouch Label] H74917540. Sterilized
with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide
torsional control. The guidewire has a shapeable and highly radiopaque distal platinum
tip, Recall # Z-2365-2008
CODE
a) Lot / Batch #: 7908999, 7945613, 7968042, 8002696, 8049604, 8152432, 8181321, 8188798, 8189027, 8260367, 8289723, 8343908, 8350907, 8418323, 8435607, 8506420, 8529856, 8550971, 8584215, 8620500, 8632756, 8632757, 8636509, 8644935, 8656636, 9175918, 9183100, 9200564, 9455621, 9512879, 9521733, 9535932, 9656252, 9747125, 9813152, 11043633, 11122070, 11181968, 11182772, 11194875, 11259816, 11276388, 11328172, 11342423, 11363879, 11518115, 11604154, and 11665770;
b) Lot / Batch #: 7871050, 7874112, 7901492, 7908998, 7935372, 7942404, 7946750, 7951989, 7979004, 7987978, 8002687, 8002688, 8025772, 8049137, 8056451, 8076852, 8098810, 8100687, 8115174, 8152431, 8181521, 8181914, 8182172, 8188799, 8193187, 8196976, 8199191, 8200479, 8200913, 8250949, 8252697, 8254876, 8260512, 8267344, 8268818, 8276225, 8281144, 8290915, 8334503, 8344727, 8352846, 8355028, 8356527, 8364588, 8410167, 8410168, 8418161, 8436013, 8439527, 8487277, 8494510, 8494814, 8506052, 8517771, 8529765, 8533184, 8547526, 8547528, 8548109, 8563958, 8584214, 8599724, 8620506, 8621310, 8623982, 8624400, 8624593, 8636348, 8636397, 8636409, 8636503, 8641950, 8833124, 8844258, 8856203, 9095461, 9111353, 9115679, 9115681, 9127229, 9157914, 9161086, 9183101, 9183105, 9185694, 9185695, 9188841, 9200553, 9222896, 9255968, 9261438, 9296807, 9297103, 9320040, 9339417, 9339418, 9346642, 9346643, 9368448, 9431674, 9431675, 9431676, 9435282, 9477092, 9478619, 9506755, 9506757, 9506865, 9521490, 9521491, 9521492, 9569394, 9581945, 9581946, 9583721, 9598709, 9603497, 9605899, 9637090, 9640999, 9644150, 9656493, 9656494, 9687546, 9784975, 9804363, 9822697, 11070550, 11099161, 11129198, 11132701, 11181779, 11181961, 11194872, 11204324, 11205127, 11208660, 11210322, 11243379, 11257970, 11258088, 11279186, 11279187, 11304665, 11304666, 11314418, 11314419, 11331413, 11342422, 11364163, 11364164, 11364441, 11364625, 11367614, 11368112, 11381445, 11381446, 11381713, 11400941, 11400942, 11413485, 11416911, 11416912, 11419631, 11421390, 11441801, 11455976, 11466878, 11482433, 11485605, 11491642, 11566831, 11576501, 11576502, 11604153, 11610376, 11610377, 11631997, and 11632322;
c) Lot / Batch #: 8507682, 8529860, 9012874, 9249774, 9249775, and 9830636;
d) Lot / Batch #: 7873372, 7909303, 7987688, 8025769, 8049696, 8202657, 8203318, 8260511, 8289582, 8351041, 8372192, 8372883, 8410171, 8418162, 8432959, 8506417, 8533771, and 11643756
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Maple Grove, MN, by letter dated June 19, 2008.
Manufacturer: Boston Scientific Corp., Miami, FL. Firm initiated recall is ongoing.
REASON
The PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary Guidewires could be damaged in certain locations. This damage of the coating creates the potential for small particles of the PTFE coating to detach from the wire. If PTFE particles detach from the guidewire and are released into the coronary vasculature, the particles may occlude a blood vessel. The most serious adverse effect that is reasonably expected would be a myocardial infarction. The particular clinical effect(s) would depend on the site of occlusion. To date, Boston Scientific has received no complaints in association to this product issue. Further distribution or use of any remaining product affected by this recall should cease immediately.
VOLUME OF PRODUCT IN COMMERCE
22,397 single units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A streptococcal antigen directly from throat swabs; Catalog Nos. 3030-20 (20 test) and 3030-40 (40 test), Recall # Z-2427-2008
CODE
Lot No: 94300
RECALLING FIRM/MANUFACTURER
Mainline Technology, Inc., Ann Arbor, MI, by telephone and follow-up letter on or about November 6, 2006. Firm initiated recall is complete.
REASON
Use of an incorrect dropper tip on the dispenser may result in false positive A streptococcal results.
VOLUME OF PRODUCT IN COMMERCE
11,520 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ace Heat Therapy, A BD Product Up to 10 hours of Soothing Heat; Heat therapy for muscle and joint pain. Apply Directly to Skin, Instant, Air-Activated Heat Patches; Catalog Numbers: 207569, 207570, 207535, 207541, 207542, 207543, 207544, 207545, 207549, 207550, 207557, 207565, 207582, 207583, and 207586, Recall # Z-2431-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on April 25, 2008.
Manufacturer: Sanpou Chemical Co., Tokyo, Japan. Firm initiated recall is ongoing.
REASON
Potential for skin irritation and burns associated with the use of this product.
VOLUME OF PRODUCT IN COMMERCE
Approximately 703,000 patches
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Universal Optical Tracker Fixation, not sterile, REF 111.031. Surgical instrument, Recall # Z-2445-2008
CODE
Lots: 050433, BP050199, BP050258 and BP050350
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by e-mail on August 6, 2007.
Manufacturer: Orthosoft Inc., Montreal, Quebec, Canada. Firm initiated recall is complete.
REASON
Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resulting in surgical delay and an increased risk of infection.
VOLUME OF PRODUCT IN COMMERCE
39 instruments
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile,
Recall # Z-2446-2008;
b) Caption Disposable Platelet Concentrator Kit, Ref 71178202, 1 each, Sterile,
Recall # Z-2447-2008
CODE
Lot Nos.: 07EQT0003, 07EQT0004, 07EQT0005, 07JQT0003, 07KQT0002, 63207107, 07HM12429, and 07JM15582;
b) Lot Nos.: 08EQT0001, 08DQT0001, 08CQT0003, 08BQT0002, and 08AQT0003
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Memphis, TN, by e-mail on July 30, 2008 and by telephone on July 30/31, 2008. Firm initiated recall is ongoing.
REASON
Product contained a syringe whose package seal integrity can be adversely affected when the product is exposed to low atmospheric pressure. This may occur during shipping.
VOLUME OF PRODUCT IN COMMERCE
9,321 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) DYONICS 25 Fluid Management System bag for enclosure of wireless remote control
included with Disposable Inflow Tubeset. Catalog # 7211004. Bag is used for
remote Control in a sterile field, Recall # Z-2448-2008;
b) DYONICS 25 Fluid Management System bag for enclosure of wireless remote control
included with Disposable Inflow/Outflow Tubeset with Single Suction. Catalog #
7211005. Bag is used for remote in a sterile field, Recall # Z-2449-2008;
c) DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control
included with Disposable Inflow/Outflow Tubeset with Forked Suction. Catalog #
7211006. Bag is used for remote control in a sterile field, Recall # Z-2450-2008;
d) DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control
included with Disposable Patient Tubeset. Catalog # 7211008. Bag is used for remote
control in a sterile field, Recall # Z-2451-2008
CODE
a) Lot Numbers: 1548H, 1548J, 1718U, 1758F, 1848U, and 1928F;
b) Lot Numbers: 1688L, 1788H, 1798F, and 1928H;
c) Lot Numbers: 1618F, 1628F, 1758J, 1838K, and 1938F;
d) Lot Numbers:1458F, 1458J, and 1698J
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc. Endoscopy Division, Andover, MA, by letter and telephone on August 7, 2008.
Manufacturer: Smith & Nephew, Inc Endoscopy Division, Oklahoma City, OK. Firm initiated recall is ongoing.
REASON
Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.
VOLUME OF PRODUCT IN COMMERCE
22,239 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) SOMATOM Emotion 6. Computed tomography X-ray system; Model Numbers:
10165888, 10165977, and 10046789, Recall # Z-2452-2008;
b) SOMATOM Emotion 16. Computed tomography X-ray system; Model Numbers:
10165888, 10165977, and 10046789; Recall # Z-2453-2008
CODE
Model Numbers only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by Safety Update in July 2008.
Manufacturer: Siemens Shanghai Medical Equipment Ltd., Shanghai, China. Firm initiated recall is ongoing.
REASON
Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does have an inline fuse which is designed to open in the event of a short circuit condition between the internal switch contacts.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, packaged 20 per
case, Recall # Z-2454-2008;
b) Vital Signs Intubation Pack, Part Number: INTPKF, Sterile. Contains one lighted
stylet per pack, Recall # Z-2455-2008;
c) Light Wand Intro Pack, Part Number: 3960, Sterile. Contains 5 lighted stylets per
pack, Recall # Z-2456-2008
CODE
a) Lot numbers: 1188D, 1465D, 1683D, 1999D, 2165D, 2461D, 2635D, 2833D, 2856D,
3044E, 3072F, 3129D, 3355H, 3612F, 3673D, 4377F, 5495C, 5496C, 5497C, 5498C,
5668C, 5669C, 6581C, 6582C, 6730C, 7108C, 7256C, 7364C, 7861C, 7970C, 8355C,
8880C, 9233C, 9423C, 9905C, 3854F, 3945G, 3966F, 4013E, 4036N, 4078D, 4103U,
4156M, 4211K, 4222P, 4222R, 4266G, 4281C, 4294J, 4306G, 4318D, 4331A, 4339R,
4358P, 4366X;
b) Lot numbers: X144, X172, X217, X273, X299, X300, X307, X333, X350, 052A,
081A, 093A, 166A, 271A, 319A, 349A, 033D, 101D, 116D, 164D, 219D, 233D,
291D, 346D, 004F, 058F, 063F, 197F;
c) Lot numbers: 1080D, 1397D, 1623D, 2079D, 2654D, 2949D, 3165D, 3168I, 3207D,
3316H, 3583F, 3693E, 4378W, 4400P, 8045C, 9144C, 9863C, 4022K, 4059F, 4101L,
4198B, 4289Y, 4307A
RECALLING FIRM/MANUFACTURER
Vital Signs Colorado, Inc., Englewood, CO, by letter on August 11, 2008. Firm initiated recall is ongoing.
REASON
Light protector may detach from lighted stylet during intubation.
VOLUME OF PRODUCT IN COMMERCE
57,792 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500, Recall # Z-2458-2008
CODE
Serial #s: 6080185, 6080285, 6080385, 6080485, 6080585, 6080685, 6080785, 6080885, 6080985, 6081085, 6081185, 6081285, 6081385, 6081485, 6081585, 6081685, 6081785, 6081885, 6081985, 6082085, 6082185, 6082285, 6082385, 6082485, 6082585, 6082685, 6082785, 6082885, 6082985, 6083085, 6083185, 6083285, 6083385, 6083485, 6083585, 6083685, 6083785, 6083885, 6083985, 6084085, 6090185, 6090285, 6090385, 6090485, and 6090585
RECALLING FIRM/MANUFACTURER
Conmed Linvatec Endoscopy Division, Goleta, CA, by recall information packet in May 2008. Firm initiated recall is complete.
REASON
The recall was initiated because ConMed Linvatec has determined there is a possibility the wheel caster(s) may become loose which may result in the wheel caster(s) falling out of the base of the VP8500 Video Cart. The potential for the wheel caster or casters to fall out of the base of the cart may result in a potential tip hazard.
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232, Manufacture Date 2008 Jun 20, Recall # Z-2461-2008
CODE
Lot #: 551668001, Expiration Date 2010-Jun-20
RECALLING FIRM/MANUFACTURER
American Medical Systems, Minnetonka, MN, by telephone on July 17, 2008 and by letter dated July 21, 2008. Firm initiated recall is ongoing.
REASON
The carton labeling does not match the product packaged inside. The package indicated that the device is an 18cm Preconnected MS pump while it is actually an 18cm Ultrex Preconnected MS Pump.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
LA
___________________________________
PRODUCT
SoftPath ASCII Software Releases 1.2, 2.1, 2.2 and 2.3, Recall # Z-2463-2008
CODE
Version 1.2, 2.1, 2.2 and 2.3
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letter beginning February 23, 2006. Firm initiated recall is complete.
REASON
In the creation of revised report and supplemental reports diagnosis, text was inserted from another case.
VOLUME OF PRODUCT IN COMMERCE
201 units
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

___________________________________
PRODUCT
Ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-6-60-135, Use Before 2010-07, Recall # Z-1816-2008
CODE
Lot: 4401214
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, by visit on April 15, 2008. Firm initiated recall is ongoing.
REASON
An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

END OF ENFORCEMENT REPORT FOR OCTOBER 8, 2008

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