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U.S. Department of Health and Human Services

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Enforcement Report for October 1, 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 1, 2008
08-39

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
a) Golden Girl brand Mut Gung Sweetened Ginger, Net Wt: 7oz (200g), UPC 8 935129
760691. Product of Vietnam --- Nutrition Facts: Serving Size 85g (3 oz), Servings
Per Container about 3. The product is packed in a sealed, rigid plastic package,
Recall # F-572-8;
b) Ying Feng Foodstuffs brand Dried Snow Fungus, Champignon Sec DE Neige, Net
Wt: 3 oz (85 g), Product of P. R. C. --- Nutrition Facts: Serving Size 1 bowl (3.5 g),
Servings Per Container 3 --- UPC bar code 6 911749 680306 --- Storage period: 24
months. The product is packed in a sealed, flexible plastic package, Recall # F-573-8;
c) Ying Feng Foodstuffs brand Dried Bulbus Lily, Net wt: 10 oz (283g +-5g). Product
of P. R. C. --- Nutrition Facts: Serving Size 5.3 oz. (150g) Servings per Container 1.
The product is packed in a sealed, flexible plastic package; UPC bar code 6 92364
82056 3, Recall # F-574-8
CODE
UPC Code only
RECALLING FIRM/MANUFACTURER
Fine Land Corp, Brooklyn, NY, by press releases on April 8, 2008 and April 11, 2008 and followed up by letters. Firm initiated recall is complete.
REASON
The products contained undeclared sulfites based on samplings and analyses by New York State Dept. of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
a) 23 cases; b) 46 cases; c) 1 case
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Fresh Basil in 3/4 oz. clamshell containers, 6 or 12 per case; 4-oz.. clamshell containers, 12 per case; 1-lb. bunches; 1-lb. plastic bags, Recall # F-575-8
CODE
All products with dates of manufacture 7-31-08 through 8-4-08, batch codes 05213 and 05214
RECALLING FIRM/MANUFACTURER
Recalling Firm: Jacobs Farm / Del Cabo, Pescadero, CA, by telephone and e-mails on August 7, 2008.
Manufacturer: Empacadora San Jose Viejo, San Jose del Cabo, Mexico. Firm initiated recall is ongoing.
REASON
Product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approximately 8,266 lbs.
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Sandwich Juice sngne brand Sugar Fruit Flavor Chews, Net Wt. 17.6 oz (500g), Product of P.R.C. UPC 6 920546 122209. The product is packaged in a sealed, flexible plastic bag. Recall # F-555-8
CODE
Pro: 24/05/2007, Exp: 24/05/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fine Land Corp, Brooklyn, NY, by letters on/about January 3, 2008.
Manufacturer: Ying Feng Foodstuffs Co., Ltd, Jiangmen, China. Firm initiated recall is complete.
REASON
The product contains undeclared milk, a known allergen, plus undeclared colors including FD&C Yellow #5 and #6 based on inspectional findings, sampling, and analysis by New York State Department of Agriculture & Markets. There is no ingredient statement on the label.
VOLUME OF PRODUCT IN COMMERCE
17 cases
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Lobster Frozen Coconut Breaded Popcorn Shrimp 120/4 oz., The product is packed in bulk 30 lb cases. Item number 075001, Recall # F-560-8
CODE
Production code: 8183K and 8171K
RECALLING FIRM/MANUFACTURER
King & Prince Seafood, Brunswick, GA, by telephone and email on August 13, 2008. Firm initiated recall is ongoing.
REASON
Nitrofurans, a prohibited antibiotic, was detected in the product.
VOLUME OF PRODUCT IN COMMERCE
725 cases (21,750 lbs)
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
a) Ginger packaged in the following sizes and forms: (1) Frontier Natural Products
Co-Op Cut & Sifted Ginger Root Certified Organic, packaged in 16-oz. foil bags,
Item #621; (2) Frontier Natural Products Co-Op Ground Ginger Root Certified
Organic, packaged in 16-oz. foil bags, Item #2610; (3) Organic Frontier Natural
Products Co-Op Ginger Root Ground, packaged in 1.50-oz. glass bottles, Item
#18464; (4) Simply Organic ginger, packaged in 1.64-oz. glass bottles, Item #18518;
(5) Simply Organic ginger, packaged in 1.64-oz. glass bottles, Item #18554,
(6) Frontier Natural Products Co-Op Certified Organic Ginger Root Powder,
packaged in 0.93-oz. plastic pouches, Item #22036; (7) Simply Organic ginger,
packaged in 0.42-oz. plastic bottles, Item #50132; (8) Simply Organic ginger,
packaged in 0.42-oz. plastic bottles, Item #50032; (9) Frontier Natural Products
Co-Op Cut & Sifted Ginger Root Certified Organic, packaged in 400-oz. foil bags,
Item #B600621; (10) Frontier Natural Products Co-Op Ground Ginger Root Certified
Organic, packaged in 400-oz. foil bags, Item #B602610; (11) Bristol Farms Organic
Ginger, packaged in 1.50-oz. glass bottles, Item #BF00217; (12) Earth Fare Organic
Ground Ginger, packaged in 1.50-oz. glass bottles, Item #EF00305; (13) Whole
Foods Market 365 Organic brand Organic Ginger, packaged in 1.50-oz. glass bottles,
Item #W041919; (14) F/E (French/English) Simply Organic Mini Spice Shipper
(display), Item #18685, containing 12/0.42-oz. plastic bottles Simply Organic ginger,
Item #50132, from recalled lots; (15) Simply Organic Mini Spice Shipper (display),
Item #18650, containing 12/0.42-oz. plastic bottles of Simply Organic ginger, Item
#50032, from recalled lots; (16) Packaged Bulk Easter Shipper Custom (display),
Item #22094, containing 12/0.93-oz. plastic pouches of Frontier Natural Products
Co-Op Certified Organic Ginger Root Powder, Item #22036, from recalled lots;
(17) Frontier Organic Holiday Baking Shipper, Item #18255, containing 12/1.50-oz.
glass bottles of Organic Frontier Natural Products Co-Op Ginger Root Ground, Item
#18464, from recalled lots. *Number of bottles in the shippers are included in the
single bottle amounts, Recall # F-561-8;
b) Jamaican Jerk Blend packaged as follows: Frontier Natural Products Co-Op
Jamaican Jerk Blend Certified Organic, packaged in 16-oz. foil bags, item #2738;
Organic Frontier Natural Products Co-Op Jamaican Jerk, Salt-Free Blend, packaged
in 2.50-oz. glass bottles, Item #18925, Recall # F-562-8;
c) Frontier Natural Products Co-Op Pumpkin Pie Spice Certified Organic, packaged in
16-oz. foil bags, Item #2739, Recall # F-563-8;
d) Frontier Natural Products Co-Op Seasoning Salt Blend Certified Organic, packaged
in 16-oz. foil bags, Item #2783, Recall # F-564-8;
e) Frontier Natural Products Co-Op Simply Soy Burger Mix Certified Organic,
packaged in 16-oz. foil bags, item #2792, and 25-lb. boxes, Item #B602792,
Recall # F-565-8;
f) Frontier Natural Products Pickling Spice Certified Organic, packaged in 16-oz. foil
bags, Item #2901, Recall # F-566-8;
g) Simply Organic Orange Ginger Vinaigrette Salad Dressing Mix, packaged in 0.71-
oz. foil pouches, Item #18963. The salad dressing mix is also contained in the Simply
Organic Picnic Shipper display, Item #18849, containing 12 pouches per display,
Recall # F-567-8;
h) Simply Organic Grilling Seasons Seafood Seasoning, packaged in 2.93-oz. glass
bottles, Item #18965, Recall # F-568-8;
i) Organic Frontier Natural Products Co-Op Apple Pie Spice, Salt-Free Blend, packaged
in 1.69-oz. glass bottles, Item #18987, Recall # F-569-8;
j) Organic Frontier Natural Products Co-Op Seafood Seasoning, packaged in 1.98-oz.
glass bottles, Item #18990, Recall # F-570-8;
k) Frontier Natural Products Co-Op Davy Jones' Seafood Seasoning, packaged in 2.36-
oz. glass bottles, Item #18996, Recall # F-571-8
CODE
a) 1) Lot #8149; 2) Lot #7348, 8007, 8022, 8053, 8057, 8071, 8077, 8114, and 8120;
3) Lot #7341, 8021, 8032, and 8085; 4) Lot #8042, 8059, 8085, 8114, and 8126;
5) Lot #7340, 8018, 8042, 8084, 8085, and 8101; 6) Lot #8059 and 8134;
7) Lot #8022, 8079, 8109, and 8144; 8) Lot #8030, 8072, and 8081; 9) Lot #8135;
10) Lot #8057 and 8091; 11) Lot #8039; 12) Lot #8008 and 8014; 13) Lot #7339,
8024, 8032, 8063, 8080, 8109, and 8150; 14) Lot #8205, 8191, 8121, 8094, 8077,
and 7338; 15) Lot #8203, 8130, and 8022; 16) Lot #8072; 17) Lot #8095
b) Lot #8094 and 8155; Lot #8086 and 8154;
c) Lot #8120;
d) Lot #8119;
e) Lot #8100, 8127; Lot #8100 and 8128;
f) Lot #8193;
g) Lot #8136 and 8163; Shipper displays - Lot #8161, 8150, 8140, 8114, and 8093;
h) Lot #8122 and 8142;
i) Lot #8119 and 8137;
j) Lot #8121 and 8141;
k) Lot #8121 and 8129
RECALLING FIRM/MANUFACTURER
Frontier Natural Products Co-op, Norway, IA, by letters dated July 25, 2008 and by telephone beginning July 28, 2008. Firm initiated recall is ongoing.
REASON
The ginger was found to contain aldicarb, for which there is no tolerance.
VOLUME OF PRODUCT IN COMMERCE
24,234 lbs
DISTRIBUTION
Nationwide, Canada, Mexico, and the Cayman Islands

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0649-08
CODE
Unit: 9975928, Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on August 9, 2006 and follow-up letter on September 30, 2006. Firm initiated recall is complete.
REASON
Blood products, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0651-08
CODE
Unit: 9953790, Part 1, 2, and 3
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on July 12, 2007. Firm initiated recall is complete.
REASON
Platelets, with insufficient plasma volume to support the platelet yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets, Recall # B-0653-08
CODE
Unit: W084708000006
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on May 6, 2008. Firm initiated recall is complete.
REASON
Blood product, collected using expired arm preparation kit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0654-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0655-08;
c) Platelets Leukocytes Reduced, Recall # B-0656-08
CODE
a), b) and c) Unit: 019GH77240
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by telephone and facsimile on April 10, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets, Recall # B-1407-08
CODE
Unit: 4981373
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on June 26, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1755-08
CODE
Unit: 9944699, Part 1 and 2
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on March 21, 2006 and letter on March 22, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Recovered Plasma, Recall # B-2046-08
CODE
W045005107990
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, electronically on April 10, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0650-08
CODE
Units: 38FX23199A, 38FX23199B, 38FX23199C
RECALLING FIRM/MANUFACTURER
American National Red Cross Indiana-Ohio Region, Fort Wayne, IN, by letter on February 13, 2008. Firm initiated recall is complete.
REASON
Blood products, for which the quality control testing was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IN
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0652-08
CODE
Unit: 6992307
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by facsimile on February 21, 2008. Firm initiated recall is complete.
REASON
Blood product, manufactured without additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1403-08
CODE
Units: 2864092; 2864095; 2864099; 2864113; 2864114; 2864115; 2864077
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on April 21, 2006. Firm initiated recall is complete.
REASON
Blood products, collected using expired blood collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Monoclate-P Antihemophilic Factor (Human), 1000 units, Factor VIII: C Pasteurized Monoclonal Antibody Purified; an Rx product, for intravenous administration only, store at 2-8 degrees C, US License No. 1767; NDC #0053-7656-04, Recall # B-1892-08
CODE
Lot numbers: J91504, exp. April 25, 2010; J91604, exp. April 30, 2010; J91705, exp. May 02, 2010; J91806, exp. June 9, 2010
RECALLING FIRM/MANUFACTURER
CSL Behring LLC, Kankakee, IL, by telephone and follow-up recall letters dated August 18, 2008. Firm initiated recall is ongoing.
REASON
Monoclate-P lots, which did not meet the potency assay requirements for stability testing at 3 months at 5 degrees C storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
650 vials
DISTRIBUTION
CA, FL, GA, KS, ND, PA, Trinidad and Tobago

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
a) Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. 81.4 cm catheter with
length markers and guide wire, 15 T-gauge introducer needle, Sutureless pump
connector with attached 7.6 cm catheter and connector pin, Transparent Strain-relief
sleeves (2), Anchors (4), Recall # Z-2380-2008;
b) Medtronic Intrathecal Catheter, model 8731SC. 38.1 cm spinal segment with length
markers and guide wire, 66 cm pump segment, separate connector pin, 15T gauge
introducer needles (2) (11.4 cm and 9.3 cm), Transparent strain-relief sleeves (2),
Opaque Strain-relief sleeves (2), V-wing Anchors (2), Recall # Z-2381-2008;
c) Medtronic Sutureless Pump Connector Revision Kit, model 8678. Contents: Catheter
interface with attached sutureless pump connector, catheter, connector pin, and strain-
relief sleeve, Strain-relief Sleeves (2), Recall # Z-2382-2008;
d) Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC.
Contents: 66-cm pump segment with attached sutureless pump connector, spinal
segment strain-relief sleeves (2), Pump segment strain-relief sleeves (2), Connector
pin, Recall # Z-2383-2008
CODE
All SC Catheter Pump Revision Kits
RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN, by letter on June 27, 2008. Firm initiated recall is ongoing.
REASON
Disconnection of the Medtronic sutureless connector (SC) catheters from the catheter port on the pump, or occlusion between the sutureless pump connector and the catheter port on the pump.
VOLUME OF PRODUCT IN COMMERCE
21,674 devices
DISTRIBUTION
Nationwide and Internationally

****CORRECTION****

In the September 24, 2008 Enforcement Report (08-38), Recall # Z-1659-2008, under REASON – product LS-203 is incorrect it should be LS-232.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B, Recall # Z-1471-2008
CODE
Serial numbers: AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235, AS40236, AS40237
RECALLING FIRM/MANUFACTURER
Biogenex Laboratories, San Ramon, CA, by letter on January 24, 2008. Firm initiated recall is ongoing.
REASON
Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) GE Definium 8000, model 5135678, Digital Radiographic Systems,
Recall # Z-1476-2008;
b) GE Precision 500D, model 2403790-3, Radiographic and Fluoroscopic Systems,
Recall # Z-1477-2008
CODE
a) Serial numbers: 0000000002772E, 00000001191M36, 00000002065M31, 00000002650M30, 00000002753EN2, 00000002767EN2, 00000002968M36, 00000003505M35, 00000003806M37, 00000004101M32, 00000004547M36, 00000005487M34, 00000096383DP5, 00000097656DP3, 00000100740WK6, 00000114297VE5, 00000989905WK5, 00000992237WK8, 00000992321WK0, 00000992949WK8, 00000992952WK2, 00000993284WK9, 00000993807WK7, 00000994376WK2, 00000994685WK6, 00000994845WK6, 00000995791WK1, 00000995797WK8, 00000995798WK6, 00000995799WK4, 00000996181WK4, 00000996289WK5, 00000996290WK3, 00000996629WK2, 00000996739WK9, 00000996745WK6, 00000996977WK5, 00000997197WK9, 00000997198WK7, 00000997265WK4, 00000997333WK0, 00000997803WK2, 00000997808WK1, 00000997809WK9, 00000997885WK9, 00000997887WK5, 00000998455WK0, 00000998632WK4, 00000TA42184-1, 00001001026WK2, 00001001592WK3, 00001003410WK6, 00001003576WK4, 00001003925WK3, 00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004158WK0, 00001004163WK0, 00001004330WK5, 00001004331WK3, 00001004332WK1, 00001004504WK5, 00001004770WK2, 00001004771WK0, 00001004772WK8, 00001004884WK1, 00001005016WK9, 00001005017WK7, 00001005018WK5, 00001005019WK3, 00001005020WK1, 00001005021WK9, 00001005022WK7, 00001005023WK5, 00001005024WK3, 00001005026WK8, 00001005027WK6, 00001005029WK2, 00001005030WK0, 00001005031WK8, 00001005033WK4, 00001005034WK2, 00001005179WK5, 00001005181WK1, 00001005184WK5, 00001005188WK6, 00001005260WK3, 00001005698WK4, 00001005757WK8, 00001005762WK8, 00001005764WK4, 00001005841WK0, 00001005912WK9, 00001006015WK0, 00001006040WK8, 00001006043WK2, 00001006044WK0, 00001006178WK6, 00001006179WK4, 00001006469WK9, 00001006470WK7, 00001006471WK5, 00001006474WK9, 00001006475WK6, 00001006476WK4, 00001006633WK0, 00001006637WK1, 00001006664WK5, 00001006666WK0, 00001006668WK6, 00001006822WK9, 00001006833WK6, 00001006871WK6, 00001006872WK4, 00001006873WK2, 00001006874WK0, 00001006875WK7, 00001006878WK1, 00001006880WK7, 00001007160WK3, 00001007161WK1, 00001007162WK9, 00001007165WK2, 00001007166WK0, 00001007192WK6, 00001007476WK3, 00001007478WK9, 00001007498WK7, 00001007499WK5, 00001007517WK4, 00001007525WK7, 00001007528WK1, 00001007529WK9, 00001007530WK7, 00001007531WK5, 00001007532WK3, 00001007534WK9, 00001007535WK6, 00001007536WK4, 00001007563WK8, 00001007642WK0, 00001007643WK8, 00001007644WK6, 00001007645WK3, 00001007646WK1, 00001007647WK9, 00001007651WK1, 00001007715WK4, 00001007716WK2, 00001007717WK0, 00001007718WK8, 00001007719WK6, 00001007720WK4, 00001007776WK6, 00001007781WK6, 00001007785WK7, 00001007786WK5, 00001007787WK3, 00001007788WK1, 00001007903WK6, 00001007904WK4, 00001007905WK1, 00001007906WK9, 00001007907WK7, 00001007908WK5, 00001007909WK3, 00001007910WK1, 00001007911WK9, 00001007912WK7, 00001008307WK9, 00001008308WK7, 00001008309WK5, 00001008311WK1, 00001008312WK9, 00001008313WK7, 00001008314WK5, 00001008315WK2, 00001008316WK0, 00001008498WK6, 00001008499WK4, 00001008500WK9, 00001008501WK7, 00001008684WK1, 00001008686WK6, 00001008687WK4, 00001008688WK2, 00001008689WK0, 00001008690WK8, 00001008691WK6, 00001008811WK0, 00001008813WK6, 00001008814WK4, 00001008840WK9, 00001008995WK1, 00001009057WK9, 00001009059WK5, 00001009062WK9, 00001009063WK7, 00001009064WK5, 00001009065WK2, 00001009066WK0, 00001009140WK3, 00001009142WK9, 00001009144WK5, 00001009145WK2, 00001009147WK8, 00001009213WK8, 00001009217WK9, 00001009218WK7, 00001009219WK5, 00001009220WK3, 00001009222WK9, 00001009252WK6, 00001009264WK1, 00001009265WK8, 00001009267WK4, 00001009269WK0, 00001009271WK6, 00001009273WK2, 00001009374WK8, 00001009375WK5, 00001009376WK3, 00001009377WK1, 00001009378WK9, 00001009380WK5, 00001009381WK3, 00001009382WK1, 00001009528WK9, 00001009529WK7, 00001009530WK5, 00001009533WK9, 00001009534WK7, 00001009536WK2, 00001009537WK0, 00001009592WK5, 00001009604WK8, 00001009605WK5, 00001009606WK3, 00001009609WK7, 00001009707WK9, 00001009708WK7, 00001009709WK5, 00001009710WK3, 00001009712WK9, 00001009713WK7, 00001009716WK0, 00001009816WK8, 00001009817WK6, 00001009819WK2, 00001009821WK8, 00001009823WK4, 00001009876WK2, 00001009930WK7, 00001009931WK5, 00001009938WK0, 00001009976WK0, 00001009977WK8, 00001009979WK4, 00001010086WK5, 00001010098WK0, 00001010101WK2, 00001010102WK0, 00001010106WK1, 00001010107WK9, 00001010157WK4, 00001010159WK0, 00001010161WK6, 00001010162WK4, 00001010169WK9, 00001010170WK7, 00001010171WK5, 00001010238WK2, 00001010240WK8, 00001010243WK2, 00001010291WK1, 00001010292WK9, 00001010293WK7, 00001010295WK2, 00001010296WK0, 00001010297WK8, 00001010298WK6, 00001010299WK4, 00001010300WK0, 00001010348WK9, 00001010349WK7, 00001010350WK5, 00001010351WK3, 00001010354WK7, 00001010356WK2, 00001010357WK0, 00001010431WK3, 00001010432WK1, 00001010433WK9, 00001010488WK3, 00001010489WK1, 00001010490WK9, 00001010521WK1, 00001010523WK7, 00001010524WK5, 00001010526WK0, 00001010527WK8, 00001010528WK6, 00001010530WK2, 00001010625WK0, 00001010626WK8, 00001010627WK6, 00001010629WK2, 00001010631WK8, 00001010632WK6, 00001010633WK4, 00001010695WK3, 00001010696WK1, 00001010723WK3, 00001010804WK1, 00001010904WK9, 00001010906WK4, 00001010907WK2, 00001010908WK0, 00001010962WK7, 00001011079WK9, 00001011081WK5, 00001011085WK6, 00001011086WK4, 00001011088WK0, 00001011091WK4, 00001011092WK2, 00001011210WK0, 00001011211WK8, 00001011212WK6, 00001011213WK4, 00001011215WK9, 00001011218WK3, 00001011219WK1, 00001011283WK7, 00001011284WK5, 00001011285WK2, 00001011286WK0, 00001011287WK8, 00001011288WK6, 00001011289WK4, 00001011290WK2, 00001011291WK0, 00001011292WK8, 00001011330WK6, 00001011380WK1, 00001011382WK7, 00001011383WK5, 00001011387WK6, 00001011388WK4, 00001011389WK2, 00001011449WK4, 00001011452WK8, 00001011454WK4, 00001011485WK8, 00001011486WK6, 00001011488WK2, 00001011489WK0, 00001011490WK8, 00001011491WK6, 00001011494WK0, 00001011495WK7, 00001011496WK5, 00001011630WK9, 00001011631WK7, 00001011632WK5, 00001011633WK3, 00001011634WK1, 00001011635WK8, 00001011643WK2, 00001011648WK1, 00001011654WK9, 00001011697WK8, 00001011700WK0, 00001011703WK4, 00001011715WK8, 00001011716WK6, 00001011821WK4, 00001011822WK2, 00001011824WK8, 00001011825WK5, 00001011826WK3, 00001011827WK1, 00001011828WK9, 00001011829WK7, 00001011830WK5, 00001011831WK3, 00001011832WK1, 00001011926WK1, 00001011928WK7, 00001011962WK6, 00001012011WK1, 00001012012WK9, 00001012013WK7, 00001012014WK5, 00001012015WK2, 00001012117WK6, 00001012118WK4, 00001012119WK2, 00001012120WK0, 00001012121WK8, 00001012122WK6, 00001012164WK8, 00001012165WK5, 00001012173WK9, 00001012278WK6, 00001012280WK2, 00001012284WK4, 00001012285WK1, 00001012299WK2, 00001012428WK7, 00001012429WK5, 00001012430WK3, 00001012450WK1, 00001012452WK7, 00001012593WK8, 00001012594WK6, 00001012622WK5, 00001012923WK7, 00001012925WK2, 00001012927WK8, 00001012928WK6, 00001012929WK4, 00001012930WK2, 00001012931WK0, 00001013005WK2, 00001013025WK0, 00001013064WK9, 00001013100WK1, 00001013101WK9, 00001013136WK5, 00001013143WK1, 00001013145WK6, 00001013222WK3, 00001013223WK1, 00001013224WK9, 00001013225WK6, 00001013305WK6, 00001013306WK4 , 00001013334WK6, 00001013335WK3, 00001013336WK1, 00001013337WK9, 00001013621WK6, 00001013622WK4, 00001015809WK5, 00002UA5040SGX, 00002UA52707GV;
b) Serial numbers: 00001014958WK1, 100963570, 00000086203DP7, 00000086475DP1, 00000086507DP1, 00000089131DP7, 00000993365WK6, 00000994505WK6, 00000995353WK0, 00000996209WK3, 00000996212WK7, 00000996789WK4, 00001000009WK9, 00001002273WK9, 00001002491WK7, 00001009077WK7, 00001009774WK9, 00001009986WK9, 00001010013WK9, 00001010015WK4, 00001010016WK2, 00001010017WK0, 00001010018WK8, 00001010020WK4, 00001010021WK2, 00001010059WK2, 00001010060WK0, 00001010061WK8, 00001010062WK6, 00001010063WK4, 00001010064WK2, 00001010065WK9, 00001010066WK7, 00001010068WK3, 00001010091WK5, 00001010120WK2, 00001010208WK5, 00001010209WK3, 00001010210WK1, 00001010212WK7, 00001010213WK5, 00001010214WK3, 00001010216WK8, 00001010217WK6, 00001010287WK9, 00001010328WK1, 00001010329WK9, 00001010330WK7, 00001010333WK1, 00001010334WK9, 00001010335WK6, 00001010336WK4, 00001010337WK2, 00001010550WK0, 00001010551WK8, 00001010552WK6, 00001010553WK4, 00001010554WK2, 00001010555WK9, 00001010739WK9, 00001010741WK5, 00001010743WK1, 00001010744WK9, 00001010746WK4, 00001010747WK2, 00001010748WK0, 00001010854WK6, 00001010855WK3, 00001010856WK1, 00001010859WK5, 00001010860WK3, 00001010861WK1, 00001010862WK9, 00001010863WK7, 00001011010WK4, 00001011011WK2, 00001011012WK0, 00001011013WK8, 00001011014WK6, 00001011029WK4, 00001011030WK2, 00001011031WK0, 00001011033WK6, 00001011035WK1, 00001011036WK9, 00001011037WK7, 00001011200WK1, 00001011201WK9, 00001011202WK7, 00001011203WK5, 00001011204WK3, 00001011205WK0, 00001011206WK8, 00001011207WK6, 00001011208WK4, 00001011209WK2, 00001011320WK7, 00001011321WK5, 00001011327WK2, 00001011328WK0, 00001011341WK3, 00001011342WK1, 00001011343WK9, 00001011344WK7, 00001011345WK4, 00001011346WK2, 00001011347WK0, 00001011348WK8, 00001011349WK6, 00001011513WK7, 00001011514WK5, 00001011515WK2, 00001011516WK0, 00001011517WK8, 00001011518WK6, 00001011519WK4, 00001011520WK2, 00001011521WK0, 00001011657WK2, 00001011762WK0, 00001011763WK8, 00001011764WK6, 00001011765WK3, 00001011766WK1, 00001011767WK9, 00001011768WK7, 00001011769WK5, 00001011770WK3, 00001011875WK0, 00001011876WK8, 00001011877WK6, 00001011878WK4, 00001011879WK2, 00001011887WK5, 00001011888WK3, 00001011889WK1, 00001011890WK9, 00001011891WK7, 00001012024WK4, 00001012025WK1, 00001012026WK9, 00001012027WK7, 00001012028WK5, 00001012029WK3, 00001012030WK1, 00001012031WK9, 00001012032WK7, 00001012033WK5, 00001012176WK2, 00001012177WK0, 00001012178WK8, 00001012179WK6, 00001012180WK4, 00001012181WK2, 00001012182WK0, 00001012183WK8, 00001012186WK1, 00001012187WK9, 00001012188WK7, 00001012189WK5, 00001012190WK3, 00001012191WK1, 00001012192WK9, 00001012193WK7, 00001012194WK5, 00001012195WK2, 00001012432WK9, 00001012434WK5, 00001012435WK2, 00001012499WK8, 00001012500WK3, 00001012501WK1, 00001012502WK9, 00001012503WK7, 00001012505WK2, 00001012506WK0, 00001012508WK6, 00001012541WK7, 00001012542WK5, 00001012543WK3, 00001012546WK6, 00001012547WK4, 00001012548WK2, 00001012549WK0, 00001012881WK7, 00001012883WK3, 00001012884WK1, 00001012885WK8, 00001012888WK2, 00001012889WK0, 00001012991WK4, 00001012992WK2, 00001012993WK0, 00001012995WK5, 00001012996WK3, 00001012997WK1, 00001013087WK0, 00001013088WK8, 00001013089WK6, 00001013090WK4, 00001013102WK7, 00001013176WK1, 00001013177WK9, 00001013178WK7, 00001013179WK5, 00001013181WK1, 00001013182WK9, 00001013183WK7, 00001013184WK5, 00001013185WK2, 00001013293WK4, 00001013294WK2, 00001013298WK3, 00001013299WK1, 00001013302WK3, 00001013576WK2, 00001013577WK0, 00001013578WK8, 00001013579WK6, 00001013580WK4, 00001013581WK2, 00001013582WK0, 00001013583WK8, 00001013584WK6, 00001013585WK3, 00001013726WK3, 00001013728WK9, 00001013729WK7, 00001013731WK3, 00001013732WK1, 00001013733WK9, 00001013734WK7, 00001013735WK4, 00001013968WK1, 00001013969WK9, 00001013970WK7, 00001013974WK9, 00001013976WK4, 00001013977WK2, 00001014092WK9, 00001014093WK7, 00001014095WK2, 00001014097WK8, 00001014098WK6, 00001014099WK4, 00001014279WK2, 00001014280WK0, 00001014392WK3, 00001014394WK9, 00001014395WK6, 00001014397WK2, 00001014398WK0, 00001014549WK8, 00001014550WK6, 00001014551WK4, 00001014553WK0, 00001014556WK3, 00001014702WK3, 00001014703WK1, 00001014704WK9, 00001014705WK6, 00001014706WK4, 00001014707WK2, 00001014710WK6, 00001014711WK4, 00001014866WK6, 00001014953WK2, 00001014959WK9, 00001014960WK7, 00001014961WK5, 00001014962WK3, 00001015088WK6, 00001015092WK8, 00001015093WK6, 00001015096WK9, 00001015219WK7, 00001015220WK5, 00001015292WK4, 00001015293WK2, 00001015295WK7, 00001015297WK3, 00001015298WK1, 00001015559WK6, 00001015563WK8, 00001015689WK1, 00002AU53105K0, 00002UA4490WQG, 00002UA4490WQM, 00002UA4490WQV, 00002UA4510C3B, 00002UA4510C3J, 00002UA45200NH, 00002UA45200NM, 00002UA45200NR, 00002UA45200QY, 00002UA50306KL, 00002UA50306KT, 00002UA50306KW, 00002UA50306L6, 00002UA50306L7, 00002UA50306L8, 00002UA50306LD, 00002UA5030PTY, 00002UA5030PTZ, 00002UA5030PV2, 00002UA5040SH5, 00002UA504DSH3, 00002UA504OSH5, 00002UA5050FP7, 00002UA5080W88, 00002UA5080W89, 00002UA5100TCV, 00002UA510147Y, 00002UA51411JC, 00002UA51411JF, 00002UA51411JG, 00002UA51411JM, 00002UA51411JN, 00002UA51411JT, 00002UA51411JY, 00002UA51411JZ, 00002UA51604QS, 00002UA51604QV, 00002UA51604QY, 00002UA51604R2, 00002UA51604R3, 00002UA51604R4, 00002UA51604R6, 00002UA51604R9, 00002UA51604RH, 00002UA51701BZ, 00002UA51701C2, 00002UA51701C5, 00002UA51701C6, 00002UA51701C8, 00002UA51701CH, 00002UA52111XQ, 00002UA52111XR, 00002UA52111XS, 00002UA52111XT, 00002UA52111XV, 00002UA52111XW, 00002UA52111XX, 00002UA5220564, 00002UA5220BKM, 00002UA5220BKP, 00002UA5220BKV, 00002UA5220S5X, 00002UA5220S5Y, 00002UA5220S5Z, 00002UA5220S62, 00002UA5220S63, 00002UA52606Q5, 00002UA52606QC, 00002UA52606QD, 00002UA52707GY, 00002UA52707GZ, 00002UA527115R, 00002UA527115V, 00002UA527115Z, 00002UA5290DD1, 00002UA5290DD2, 00002UA53006LM, 00002UA53006LN, 00002UA53006LP, 00002UA53006LR, 00002UA53006LS, 00002UA53006LT, 00002UA53006LV, 00002UA5320FKJ, 00002UA5320FKM, 00002UA5320FKN, 00002UA5320FKR, 00002UA53405P5, 00002UA53405P7, 00002UA53405P9, 00002UA53405PG, 00002UA5340LCV, 00002UA5340LCY, 00002UA5340VDC, 00002UA5340VDG, 00002UA5340VDK, 00002UA5340VDL, 00002UA535112H, 00002UA5360CBD, 00002UA5360CBG, 00002UA5360CBM, 00002UA5360CBN, 00002UA53707WM, 00002UA53707WQ, 00002UA53707WR, 00002UA53802GP, 00002UA5400VB7, 00002UA5400VB8, 00002UA541113W, 00002UA541113X, 00002UA5411140, 00002UA5411142, 00002UA5411143, 00002UA5411144, 00002UA5411146, 00002UA5411147, 00002UA5411148, 00002UA5411149, 00002UA541114B, 00002UA541114H, 00002UA542046N, 00002UA542046P, 00002UA542046Q, 00002UA542046R, 00002UA542046T, 00002UA542046V, 00002UA5420VPK, 00002UA5420VPM, 00002UA5420VPP, 00002UA5430X4Y, 00002UA5440B2V, 00002UA5440B2W, 00002UA5450SNN, 00002UA5450SNR, 00002UA5450SNY, 00002UA60200GH, 00002UA606KJH4, 00002UA606KJH7, 00002UA615JV3C, 0000USU4350N51, 0000USU4400NXF, 0000USU4400NXJ, 0000USU4400NXQ, 0000USU4400NXV, 0000USU4400NXW, 0000USU4400NXY, 0000USU4400NY0, 00010103324WK3, 0UNK2289299-01, , 00000114134VE0
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by site visit. Firm initiated recall is ongoing.
REASON
Necessary certification labels are missing from the x-ray control.
VOLUME OF PRODUCT IN COMMERCE
885 systems
DISTRIBUTION
Nationwide, Italy, Japan, Spain and Turkey
___________________________________
PRODUCT
1) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain , 3,2mm, 10Fr,
PVC, 107cm, medium, sterile, latex free, Rx only; REF 00-2555-020-05, Recall #
Z-1480-2008;
2) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 3/16" Soft Drain , 4,8mm,
15Fr, PVC, 107cm, firm, sterile, latex free, Rx only; REF 00-2555-030-05, Recall #
Z-1481-2008;
3) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/4" Drain, 6,4mm, 19Fr,
PVC, 107cm, large, sterile, latex free, Rx only; REF 00-2555-040-05, Recall #
Z-1482-2008;
4) Zimmer H.A.S. Autotransfusion System, H.A.S. Replacement Kit, sterile, latex free,
Rx only; REF 00-2555-050-05, Recall # Z-1483-2008;
5) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit without Drain, sterile, latex free,
Rx only; REF 00-2555-060-05, Recall # Z-1484-2008;
6) Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 1/8" PVC w/trocar,
3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF 00-2500-000-10,
Recall # Z-1485-2008;
7) Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 1/8" PVC
w/trocar, 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF 00-
2500-700-10, Recall # Z-1486-2008;
8) Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 3/16" PVC w/trocar,
4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; REF 00-2505-000-10,
Recall # Z-1487-2008;
9) Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 3/16" PVC
w/trocar, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; REF 00-2505-
700-10, Recall # Z-1488-2008;
10) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection
Control Kit w/ 3/32" Drain, 2,4mm, 7Fr, PVC, 107cm, small, sterile, latex free, Rx
only; REF 00-2550-001-10, Recall # Z-1489-2008;
11) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection
Control Kit w/ 1/8" Drain, 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free,
Rx only; REF 00-2550-002-10, Recall # Z-1490-2008;
12) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection
Control Kit w/ 3/16" Drain, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free,
Rx only; REF 00-2550-003-10, Recall # Z-1491-2008;
13) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection
Control Kit w/ 1/4" Drain, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free,
Rx only; REF 00-2550-004-10, Recall # Z-1492-2008;
14) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection
Control Kit w/ 1/8" Drain Spec., 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex
free, Rx only; REF 00-2550-702-10, Recall # Z-1493-2008;
15) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection
Control Kit w/ 3/16" Drain Spec., 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex
free, Rx only; REF 00-2550-703-10, Recall # Z-1494-2008;
16) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml Infection
Control Kit w/ 1/4" Drain Spec, 6,4mm, 19Fr, PVC, 107cm, large,
sterile, latex free, Rx only; REF 00-2550-704-10, Recall # Z-1495-2008;
17) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, Mini-Hemovac
I.C. Kit, sterile, latex free, Rx only; REF 00-2557-000-10, Recall # Z-1496-2008;
18) Zimmer Hemovac Wound Drainage Device, 100 ml Hemovac Mini Evacuator,
sterile, latex free, Rx only; REF 00-2568-000-10, Recall # Z-1497-2008;
19) immer Hemovac Wound Drainage Device, 400 ml COMP EVAC 1/4" PVC w/trocar
(4"), 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF 00-2590-000-
10, Recall # Z-1498-2008;
20) Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 1/4" PVC
w/trocar, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF 00-2590-
040-10, Recall # Z-1499-2008;
21) Zimmer Hemovac Wound Drainage Device, 400 ml EVAC 1/4" DR w/troc spec.,
6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF 00-2590-700-10,
Recall # Z-1500-2008;
22) Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 3/32" PVC
w/trocar, 2,4mm, 7Fr, PVC, 107cm, small, sterile, latex free, Rx only; REF 00-2595-
000-10, Recall # Z-1501-2008;
23) Zimmer Hemovac Wound Drainage Device with O.P. Adapter, 400 ml COMP EVAC
w/O.P. Adapter Component Kit, to be used with OrthoPAT post op suction set,
sterile, latex free, Rx only; REF 00-2696-000-10, Recall # Z-1502-2008;
24) Surgivac Wound Drainage Device, 400 ml Surgivac 1/8" PVC w/trocar, 3,2mm,
10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF 00-5300-000-05 and
00-5300-000-10, Recall # Z-1503-2008;
25) Surgivac Wound Drainage Device, 400 ml Surgivac Component Kit, sterile, latex
free, Rx only; REF 00-5300-004-10; Recall # Z-1504-2008;
26) Surgivac Wound Drainage Device, 400 ml Surgivac 3/16" PVC w/trocar, 4,8mm,
15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; REF 00-5305-000-05 and
00-5305-000-10, Recall # Z-1505-2008;
27) Surgivac Wound Drainage Device, 400 ml Surgivac 1/8" MP Sil w/trocar, 3,2mm,
10Fr, Si, 107cm, medium, sterile, latex free, Rx only; REF 00-5340-000-05 and
00-5340-000-10, Recall # Z-1506-2008;
28) Surgivac Wound Drainage Device, 400 ml Surgivac 3/16" MP SIL w/trocar, 4,
8mm, 15Fr, Si, 107cm, soft, sterile, latex free, Rx only; REF 00-5341-000-05 and
00-5341-000-10, Recall # Z-1507-2008;
29) Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" MP SIL w/trocar, 6,4mm,
19Fr, Si, 107cm, large, sterile, latex free, Rx only; REF 00-5345-000-10,
Recall # Z-1508-2008;
30) Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" PVC w/trocar, 6,4mm,
19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF 00-5390-040-10,
Recall # Z-1509-2008
CODE
All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, by letters dated January 29, 2008, and March 17, 2008.
Manufacturer: Zimmer Orthopedic Surgical Products, Dover, OH. Firm initiated recall is ongoing.
REASON
The sterility of the device may be compromised due to the possible presence of slits or pinholes in the packaging.
VOLUME OF PRODUCT IN COMMERCE
377,707 packages
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Stryker Medical Secure II Med/Surg Bed, 115 V, Model 3002, Recall # Z-1685-2008;
b) Stryker Medical Epic II Critical Care Bed, 115 V, Model 2030, Recall # Z-1686-2008;
c) Stryker Medical Epic II Critical Care Bed with Zoom Drive System, 115 V, Model
2040, Recall # Z-1687-2008;
d) Stryker Medical Secure II Med/Surg Bed, 230 V, Model 3221 (not sold in the U.S.),
Recall # Z-1688-2008;
e) Stryker Medical Epic II Critical Care Bed, 230 V, Model 2031, (not sold in the U.S.),
Recall # Z-1689-2008
CODE
a) Serial numbers 040915077 through 071116347;
b) Serial numbers 0409060501 through 0711096119;
c) Serial numbers 0409060516 through 0711096116;
d) Serial numbers 040915077 through 071116347;
e) Serial numbers 0409060501 through 0711096119
RECALLING FIRM/MANUFACTURER
Stryker Medical Division of Stryker Corp., Portage, MI, by letter dated February 1, 2008. Firm initiated recall is ongoing.
REASON
The brakes may not have adequate holding power to lock the bed in place.
VOLUME OF PRODUCT IN COMMERCE
66,558 beds
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Universal Notch Preparation Guide, Size #3; Non Sterile; Catalog Number 7650-3363,
Recall # Z-1690-2008;
b) X-Celerate Universal Block Pegless Size #3, Non Sterile; Catalog Number 8000-3303,
Recall # Z-1691-2008
CODE
All lot codes since 1998
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letters on March 18, 2008. Firm initiated recall is ongoing.
REASON
Discovery of the potential for Pin and Punch interference of the Size 3 Scorpio Notch Preparation Guide that may result in damage to bone if a user aggressively attempts to seat an obstructed punch.
VOLUME OF PRODUCT IN COMMERCE
2,580 units
DISTRIBUTION
Nationwide and Internationally
`___________________________________
PRODUCT
iLab Ultrasound Imaging System, Models 120INS and 240INS; UPN’s: H74900036130, H749FG000940, H749ILAB120INS0, H749ILAB120INSR0, H749ILAB220INS0, H749240INS0, M004EPIL120INS0, Recall # Z-1693-2008
CODE
Serial numbers 0000004082, 0000004385, 0000004386, 0000004387, 0000004388, 0000004389, 0000004390, 0000004391, 0000004392, 0000004393, 0000004396, 0000004397, 0000004398, 0000004399, 0000004416, 0000004417, 0000004418, 0000004419, 0000004420, 0000004421, 0000004422, 0000004423, 0000004424, 0000004425, 0000004426, 0000004427, 0000004428, 0000004429, 0000004430, 0000004431, 0000004432, 0000004433, 0000004434, 0000004435, 0000004436, 0000004439, 0000004441, 0000004442, 0000004443, 0000004444, 0000004445, 0000004446, 0000004447, 0000004448, 0000004453, 0000004454, 0000004455, 0000004456, 0000004468, 0000004469, 0000004472, 0000004473, 0000004480, 0000004487, 0000004488, 0000004489, 0000004490, 0000004491, 0000004494, 0000004495, 0000004496, 0000004497, 0000004498, 0000004505, 0000004506, 0000004507, 0000004512, 0000004513, 0000004514, 0000004515, 0000004516, 0000004520, 0000004521, 0000004522, 0000004523, 0000004524, 0000004525, 0000004526, 0000004529, 0000004538, 0000004539, 0000004548, 0000004549, 0000004550, 0000004551, 0000004556, 0000004557, 0000004558, 0000004559, 0000004564, 0000004565, 0000004566, 0000004567, 0000004572, 0000004573, 0000004574, 0000004575, 0000004580, 0000004581, 0000004582, 0000004583, 0000004584, 0000004585, 0000004586, 0000004587, 0000004610, 0000004702, 0000004703, 0000004704, 0000004705, 0000004717, 0000004718, 0000004719, 0000004720, 0000004726, 0000004728, 0000004729, 0000004730, 0000004731, 0000004732, 0000004737, 0000004738, 0000004751, 0000035228, 0000035229, 0000035390, 0000035391, 0000036314, 0000094718, 0009430893, 0009503458, 0009543381, 0009565345, 0009902558, 0009602559, 0009626567, 0009640091, 0009828054, 0009828055, 0009828344, 0011008866
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Fremont, CA, by letters on April 4 and 10, 2008. Firm initiated recall is complete.
REASON
Improperly terminated wires on a component of the iLab Acquisition processor power supply could cause the processor to lock-up or stop, and prolong the patient’s procedure.
VOLUME OF PRODUCT IN COMMERCE
120 units
DISTRIBUTION
Nationwide, Hong Kong, Great Britain, Austria and France
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PRODUCT
GE OEC 9600 C-arm Fluoroscopy System, Recall # Z-1709-2008
CODE
Serial numbers: 69-1484, 69-3633, 69-3707, 69-1266-RC, 6C-0009-S, 62-0134, 69-1332, 69-3582, 69-3324, 69-2816, 62-0117, 69-2154, 65-0221, 69-2620, 69-2556, 69-0150, 69-3741, 62-0082, 62-0367, 62-0110-RC, 69-2574, 69-0313, 69-3774, 69-0108, 69-2878, 69-0195, 69-0028, 69-3580, 62-0473, 69-2035, 69-2881, 69-2775, 69-2234, 62-0261, 6S-0093-C, 69-2639-C, 69-2615, 69-2882, 62-0154, 69-1075, 69-1440, 6S-0044, 69-0357, 69-3130, 69-2699, 69-3876, 62-0086, 69-2716, 6S-0213, 69-2891, 62-0222, 69-2046, 69-2127, 69-2297, 69-2760, 69-2999-RC1, 69-3245, 6S-0137-C, 6S-0051C, 69-1022, 69-3026, 62-0087, 6S-0079-C, 69-0343, 62-0159, 69-0216, 62-0611, 69-2904, 69-3875, 69-3769, 6S-0199, 69-2767, 69-1087, 69-1401, 62-0239, 69-3519, 69-2592, 69-0282, 69-3776, 69-0436, 69-3145, 69-2320, 69-3577, 69-2621, 69-2553, 69-1188-RC, 69-0082, 6S-0228, 69-3833, 69-1009, 69-3668, 6S-0233, 69-0397, 69-2884, 69-1341, 69-0429, 69-3157, 69-0041, 69-3486, 69-1040, 69-2642, 62-0203, 69-3808, 69-0432, 69-3792, 62-0132, 62-0350, 69-2814, 65-0087-C, 6S-0086-C, 6S-0170, 66-0046, 69-0482, 69-2983, 69-335C, 69-2542, 69-2436-RC, 69-2634, 69-2879, 69-3866, 62-0481-C, 62-0600, 69-2916, 69-3368, 69-0304, 69-2781, 69-3409, 69-0243, 69-3258, 62-0100, 69-1348, 69-2222, 69-2126, 69-2293, 69-3512, 69-3888, 69-2545, 69-0094, 69-2873, 69-2870, 69-2874, 6S-0251, 69-3467-C, 69-2702, 69-1391, 69-3811, 6S-0156, 6S-0063, 69-1461, 69-3260, 69-3716, 69-3084, 69-2539, 69-3907, 62-0127, 6C-0042-RF, 69-3113, 69-3766, 69-0479, 62-0365, 69-2227, 69-3835-RC, 69-0066, 6S-0283, 69-1306, 69-2562, 69-1001, 69-1437, 69-3202, 69-0119, 69-2617, 6C-0017-RC, 69-1020, 69-2263, 69-0086, 69-3397, 62-0347, 69-0042, 62-0429, 69-3476, 69-0452, 69-0382, 6C-0015, 62-0126, 62-0596, 69-1454, 69-0360-RC, 69-2913, 69-1416, 69-2567, 69-2675, 62-0051, 69-2885, 6S-0197, 69-2268, 69-2269, 69-0068, 69-3232, 69-2348, 69-3312, 69-2611-C, 69-2591, 69-3837, 69-3618, 69-0130, 69-2405, 62-0604, 69-2828, 69-0289, 69-3740, 69-1227, 69-2968, 69-0135, 69-2654-C, 69-2941, 69-2142, 62-0054, 69-3705, 6S-0217, 69-1189, 69-2271, 69-0093, 6S-0301, 69-2521, 69-0205-RC, 69-2706, 69-3481, 69-2031, 62-0223, 69-1280, 69-1427-RC, 69-2773-RC, 6S-0128, 69-2725, 69-3804, 69-1472-RC, 69-0098, 69-3162, 69-0156, 62-0468, 69-3899, 69-2684, 69-0414, 69-1508, 69-0283, 69-2299-RC, 69-2079, 69-3654, 69-1413, 69-2285, 62-0560, 69-0183, 69-1027-RM, 62-0337, 69-0026, 69-3755, 69-3856, 69-2748, 69-2746, 65-0297, 69-3821, 69-2533, 69-3585, 69-3564, 69-2756, 69-0021, 69-2616, 69-1411, 69-0384, 69-3191, 69-3639-RC, 69-1011, 69-3807, 69-3470, 69-1173, 69-3253, 69-3541, 69-2623, 69-2625-C, 69-2758, 62-0073, 69-0081, 6S-0208, 6S-0209-C, 69-0020, 69-1486, 69-3640, 6S-0141, 69-2061-RC, 6S-0144, 69-3719, 69-2479, 69-3361, 69-2792, 62-0274, 69-2368, 69-2059, 69-2963-RC, 6S-0161-C, 69-1324, 69-1433, 69-2548, 69-3438, 62-0155, 62-0377, 6S-0184-C, 62-0016, 69-2589, 62-0340, 62-0040, 6S-0101-C, 69-2194, 69-2024, 69-3077, 69-0427, 69-3190, 69-0097, 69-2581, 69-2550, 69-3608, 6S-0114, 69-0402, 62-0081, 69-1405, 6S-0250, 69-3032, 69-1449, 69-2583, 69-2544, 69-1383, 6S,0106, 69-2053, 6S-0050, 69-2391, 69-3878, 69-0474, 69-3902, 69-1404, 69-2943, 69-0060, 6S-0055-C-RC, 62-0092, 69-2549, 62-0441, 62-0161, 69-3223, 69-3212, 69-1006, 62-0108, 69-3471, 6S-0256, 69-1496, 69-2025, 6S-0004, 69-3686, 69-3388, 69-1032, 69-3053, 69-3441, 62-0068, 69-1386, 69-3905, 69-2596-C, 69-2338, 69-2115, 69-0337, 69-2034, 69-2686, 69-3429, 69-2764, 62-0385, 69-3777-RC, 69-3088, 69-2701, 69-3767, 62-0474, 69-2692, 69-2555, 6S-0002, 6S-0133, 69-0234, 69-2375, 6C-0004, 69-0100, 69-3612, 69-0172, 69-3183, 69-2597-C, 69-0027, 69-1264, 62-0076, 6C-0005, 69-2441, 62-0047, 62-0136, 69-1334, 69-2413, 69-3198, 69-3259, 69-2323, 69-1392, 69-3657, 69-3825, 69-1441, 62-0085, 69-2033, 62-0578, 69-2653-C, 69-0386, 62-0069, 69-2783, 69-1381, 6S-0131, 62-0160, 69-3841, 69-2543, 69-2485, 69-1477, 69-2278, 69-3242, 69-0069, 69-2827-RC, 69-3733-RC, 69-2203, 69-0087, 62-0518, 69-1473, 69-3854, 69-1042, 69-0101, 69-0139, 69-0155, 69-0453, 6S-0132, 69-2613, 69-2851, 6S-0181, 6S-0082-C, 62-0496, 69-1390, 69-3892, 69-3166, 69-2063, 69-3020, 6S-0061-RC, 6C-0023-RC, and 6S-0187
RECALLING FIRM/MANUFACTURER
OEC Medical Systems, Inc., Salt Lake City, UT, by letters on July 2, 2008. Firm initiated recall is ongoing.
REASON
Secondary collimator filters may be missing on certain x-ray units. It was discovered that the secondary collimator filter on some OEC 9600 C-arms was omitted when a collimator assembly was replaced. This would reduce the filtration and therefore the Half-Value-Layer (HVL) of the X-ray beam, and may result in non-compliance with respect to Maximum Entrance Exposure Rate (EER) unless the maximum EER verification and/or calibration were performed after collimator replacement.
VOLUME OF PRODUCT IN COMMERCE
700 units
DISTRIBUTION
Nationwide
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PRODUCT
a) Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile. A combination of
legally marketed medical devices placed into one container for the convenience of
the user and used within the limits of the products' intended uses, Recall # Z-1808-
2008;
b) Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02159A, Sterile. A combination of
legally marketed medical devices placed into one container for the convenience of
the user and used within the limits of the products' intended uses, Recall # Z-1809-
2008
CODE
a) Lot: V477096;
b) Lot: V477095
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merit Medical Systems, Inc., South Jordan, UT, by visit on April 14, 2008.
Manufacturer: Zimmer, Inc., Warsaw, IN. Firm initiated recall is complete.
REASON
Sterility Compromised: Component of convenience kit was recalled by its manufacturer for non-sterility.
VOLUME OF PRODUCT IN COMMERCE
60 kits
DISTRIBUTION
Nationwide
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PRODUCT
GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis, Recall # Z-1822-2008
CODE
00000002047M39, 00000005487M34, 00000096986DP%, 00000100740WK6, 00000TA41882-7, 00000TA41972-3, 00000TA41984-4, 00000TA41984-6, 00000TA42274-8, 00000TA42869-6, 00001004330WK5, 00001004332WK1, 00001004504WK5, 00001004505WK2, 00001004510WK2, 00001004513WK6, 00001004764WK5, 00001004765WK2, 00001004766WK0, 00001004768WK6, 00001004770WK2, 00001004772WK8, 00001005020WK1, 00001005022WK7, 00001005024WK3, 00001005030WK0, 00001005031WK8, 00001005035WK9, 00001005181WK1, 00001005182WK9, 00001005188WK6, 00001005260WK3, 00001005339WK5, 00001005758WK6, 00001005914WK5, 00001006042WK4, 00001006474WK9, 00001006635WK5, 00001006637WK1, 00001006638WK9, 00001006668WK6, 00001006871WK6, 00001007161WK1, 00001007166WK0, 00001007403WK7, 00001007404WK5, 00001007480WK5, 00001007536WK4, 00001007644WK6, 00001007650WK3, 00001007907WK7, 00001008312WK9, 00001008314WK5, 00001008497WK8, 00001008684WK1, 00001008807WK8, 00001008813WK6, 00001009140WK3, 00001009143WK7, 00001009145WK2, 00001009216WK1, 00001009268WK2, 00001009375WK5, 00001009380WK5, 00001009382WK1, 00001009709WK5, 00001009818WK4, 00001009875WK4, 00001009934WK9, 00001009976WK0, 00001010085WK7, 00001010099WK8, 00001010161WK6, 00001010239WK0, 00001010294WK5, 00001010295WK2, 00001010297WK8, 00001010431WK3, 00001010488WK3, 00001010524WK5, 00001010628WK4, 00001010629WK2, 00001010687WK0, 00001010693WK8, 00001010695WK3, 00001010906WK4, 00001010907WK2, 00001010964WK3, 00001011084WK9, 00001011085WK6, 00001011092WK2, 00001011215WK9, 00001011285WK2, 00001011289WK4, 00001011386WK8, 00001011455WK1, 00001011488WK2, 00001011490WK8, 00001011647WK3, 00001011654WK9, 00001011700WK0, 00001011712WK5, 00001011822WK2, 00001011825WK5, 00001011827WK1, 00001011828WK9, 00001011829WK7, 00001011832WK1, 00001012012WK9, 00001012119WK2, 00001012286WK9, 00001012449WK3, 00001012450WK1, 00001012453WK5, 00001012923WK7, 00001013064WK9, 00001013067WK2, 00001013100WK1, 00001013101WK9, 00001013134WK0, 00001013136WK5, 00001013223WK1, 00001013334WK6, 00001013336WK1, 00001013622WK4, 00001014310WK5, 00001014936WK7, 00001016147WK9
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by letter dated March 7, 2008. Firm initiated recall is ongoing.
REASON
Loss of image data: Software anomaly in the Processing Software on the Definium 8000 system may impact patient safety when using the VolumeRAD advanced application (option). The slice visualization of VolumeRAD exams acquired on the wallstand receptor will be offset by 17mm. This prevents the visualization of anatomy WITHIN a distance of 17mm from the wallstand patient barrier (receptor cover). This lost anatomy cannot be recovered or visualized by retrospective reconstruction processing.
VOLUME OF PRODUCT IN COMMERCE
127 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
GE Healthcare Definium 8000 Digital Radiographic System, Recall # Z-1882-2008
CODE
0000000002772E, 00000001191M36, 00000001561M30, 00000001895M32, 00000002041M32, 00000002051M31, 00000002052M39, 00000002065M31, 00000002364M38, 00000002439M38, 00000002441M34, 00000002650M30, 00000002767EN2, 00000002771M34, 00000002968M36, 00000003468M36, 00000003505M35, 00000003806M37, 00000004101M32, 00000004105M33, 00000004199M36, 00000004442M30, 00000096383DP5, 00000096401DP5, 00000097412DP1, 00000097656DP3, 00000097918DP7, 00000114134VE0, 00000114297VE5, 00000114452VE6, 00000TA41711-6, 00000TA41732-3, 00000TA41827-4, 00000TA41867-8, 00000TA41882-7, 00000TA41896Ë4, 00000TA41972-3, 00000TA41984-4, 00000TA41984-6, 00000TA41995-7, 00000TA42004Ë5, 00000TA42007-4, 00000TA42020-3, 00000TA42025Ë4, 00000TA42274-8, 00000TA42869-6, 00001003925WK3, 00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004163WK0, 00001004319WK8, 00001004331WK3, 00001004508WK6, 00001004509WK4, 00001004512WK8, 00001004763WK7, 00001004767WK8, 00001004769WK4, 00001004771WK0, 00001005016WK9, 00001005017WK7, 00001005018WK5, 00001005019WK3, 00001005021WK9, 00001005023WK5, 00001005025WK0, 00001005026WK8, 00001005027WK6, 00001005029WK2, 00001005032WK6, 00001005033WK4, 00001005034WK2, 00001005179WK5, 00001005180WK3, 00001005183WK7, 00001005184WK5, 00001005185WK2, 00001005186WK0, 00001005187WK8, 00001005319WK7, 00001005669WK5, 00001005698WK4, 00001005699WK2, 00001005701WK6, 00001005702WK4, 00001005705WK7, 00001005706WK5, 00001005707WK3, 00001005755WK2, 00001005757WK8, 00001005759WK4, 00001005761WK0, 00001005762WK8, 00001005763WK6, 00001005764WK4, 00001005841WK0, 00001005911WK1, 00001005912WK9, 00001005913WK7, 00001005915WK2, 00001006015WK0, 00001006040WK8, 00001006041WK6, 00001006043WK2, 00001006044WK0, 00001006177WK8, 00001006178WK6, 00001006179WK4, 00001006469WK9, 00001006470WK7, 00001006471WK5, 00001006475WK6, 00001006476WK4, 00001006477WK2, 00001006478WK0, 00001006631WK4, 00001006633WK0, 00001006634WK8, 00001006664WK5, 00001006665WK2, 00001006666WK0, 00001006667WK8, 00001006822WK9, 00001006833WK6, 00001006834WK4, 00001006872WK4, 00001006873WK2, 00001006874WK0, 00001006875WK7, 00001006876WK5, 00001006877WK3, 00001006878WK1, 00001006880WK7, 00001007160WK3, 00001007162WK9, 00001007163WK7, 00001007164WK5, 00001007165WK2, 00001007167WK8, 00001007168WK6, 00001007169WK4, 00001007188WK4, 00001007189WK2, 00001007190WK0, 00001007191WK8, 00001007192WK6, 00001007405WK2, 00001007406WK0, 00001007407WK8, 00001007409WK4, 00001007476WK3, 00001007477WK1, 00001007478WK9, 00001007497WK9, 00001007498WK7, 00001007499WK5, 00001007516WK6, 00001007517WK4, 00001007518WK2, 00001007525WK7, 00001007527WK3, 00001007528WK1, 00001007529WK9, 00001007530WK7, 00001007531WK5, 00001007532WK3, 00001007533WK1, 00001007534WK9, 00001007535WK6, 00001007536WK4, 00001007642WK0, 00001007643WK8, 00001007645WK3, 00001007646WK1, 00001007647WK9, 00001007649WK5, 00001007651WK1, 00001007713WK9, 00001007715WK4, 00001007716WK2, 00001007717WK0, 00001007718WK8, 00001007719WK6, 00001007720WK4, 00001007721WK2, 00001007776WK6, 00001007777WK4, 00001007778WK2, 00001007779WK0, 00001007779WK0, 00001007780WK8, 00001007781WK6, 00001007782WK4, 00001007783WK2, 00001007784WK0, 00001007785WK7, 00001007786WK5, 00001007787WK3, 00001007788WK1, 00001007903WK6, 00001007904WK4, 00001007905WK1, 00001007906WK9, 00001007908WK5, 00001007909WK3, 00001007910WK1, 00001007911WK9, 00001007912WK7, 00001008307WK9, 00001008308WK7, 00001008309WK5, 00001008311WK1, 00001008313WK7, 00001008315WK2, 00001008316WK0, 00001008498WK6, 00001008499WK4, 00001008500WK9, 00001008501WK7, 00001008682WK5, 00001008685WK8, 00001008686WK6, 00001008687WK4, 00001008688WK2, 00001008689WK0, 00001008690WK8, 00001008691WK6, 00001008807WK8, 00001008808WK6, 00001008809WK4, 00001008810WK2, 00001008811WK0, 00001008812WK8, 00001008814WK4, 00001008816WK9, 00001008835WK9, 00001008837WK5, 00001008838WK3, 00001008839WK1, 00001008840WK9, 00001008841WK7, 00001008842WK5, 00001008843WK3, 00001008995WK1, 00001009057WK9, 00001009058WK7, 00001009059WK5, 00001009060WK3, 00001009061WK1, 00001009062WK9, 00001009063WK7, 00001009064WK5, 00001009065WK2, 00001009066WK0, 00001009141WK1, 00001009142WK9, 00001009144WK5, 00001009146WK0, 00001009147WK8, 00001009213WK8, 00001009215WK3, 00001009216WK1, 00001009217WK9, 00001009218WK7, 00001009219WK5, 00001009220WK3, 00001009221WK1, 00001009222WK9, 00001009252WK6, 00001009264WK1, 00001009265WK8, 00001009267WK4, 00001009268WK2, 00001009269WK0, 00001009270WK8, 00001009271WK6, 00001009273WK2, 00001009373WK0, 00001009374WK8, 00001009376WK3, 00001009377WK1, 00001009378WK9, 00001009381WK3, 00001009528WK9, 00001009529WK7, 00001009530WK5, 00001009532WK1, 00001009533WK9, 00001009534WK7, 00001009536WK2, 00001009537WK0, 00001009592WK5, 00001009593WK3, 00001009601WK4, 00001009602WK2, 00001009603WK0, 00001009604WK8, 00001009605WK5, 00001009606WK3, 00001009607WK1, 00001009609WK7, 00001009610WK5, 00001009707WK9, 00001009708WK7, 00001009710WK3, 00001009712WK9, 00001009713WK7, 00001009714WK5, 00001009716WK0, 00001009816WK8, 00001009817WK6, 00001009819WK2, 00001009821WK8, 00001009822WK6, 00001009823WK4, 00001009824WK2, 00001009873WK9, 00001009875WK4, 00001009876WK2, 00001009929WK9, 00001009930WK7, 00001009931WK5, 00001009933WK1, 00001009938WK0, 00001009977WK8, 00001009979WK4, 00001009981WK0, 00001009983WK6, 00001009984WK4, 00001009985WK1, 00001010085WK7, 00001010086WK5, 00001010098WK0, 00001010100WK4, 00001010101WK2, 00001010102WK0, 00001010103WK8, 00001010106WK1, 00001010107WK9, 00001010157WK4, 00001010158WK2, 00001010159WK0, 00001010160WK8, 00001010162WK4, 00001010167WK3, 00001010169WK9, 00001010170WK7, 00001010171WK5, 00001010238WK2, 00001010239WK0, 00001010240WK8, 00001010241WK6, 00001010242WK4, 00001010243WK2, 00001010291WK1, 00001010293WK7, 00001010296WK0, 00001010298WK6, 00001010299WK4, 00001010300WK0, 00001010348WK9, 00001010349WK7, 00001010350WK5, 00001010351WK3, 00001010354WK7, 00001010356WK2, 00001010357WK0, 00001010432WK1, 00001010433WK9, 00001010489WK1, 00001010490WK9, 00001010491WK7, 00001010493WK3, 00001010521WK1, 00001010523WK7, 00001010526WK0, 00001010527WK8, 00001010528WK6, 00001010529WK4, 00001010530WK2, 00001010625WK0, 00001010626WK8, 00001010627WK6, 00001010628WK4, 00001010630WK0, 00001010631WK8, 00001010632WK6, 00001010633WK4, 00001010693WK8, 00001010694WK6, 00001010696WK1, 00001010697WK9, 00001010698WK7, 00001010721WK7, 00001010723WK3, 00001010786WK0, 00001010804WK1, 00001010805WK8, 00001010806WK6, 00001010807WK4, 00001010808WK2, 00001010902WK3, 00001010904WK9, 00001010905WK6, 00001010911WK4, 00001010960WK1, 00001010962WK7, 00001010967WK6, 00001011022WK9, 00001011079WK9, 00001011080WK7, 00001011081WK5, 00001011082WK3, 00001011085WK6, 00001011086WK4, 00001011087WK2, 00001011088WK0, 00001011090WK6, 00001011091WK4, 00001011210WK0, 00001011211WK8, 00001011212WK6, 00001011213WK4, 00001011214WK2, 00001011216WK7, 00001011218WK3, 00001011283WK7, 00001011284WK5, 00001011286WK0, 00001011287WK8, 00001011288WK6, 00001011290WK2, 00001011291WK0, 00001011292WK8, 00001011330WK6, 00001011380WK1, 00001011382WK7, 00001011383WK5, 00001011385WK0, 00001011386WK8, 00001011387WK6, 00001011389WK2, 00001011449WK4, 00001011450WK2, 00001011700WK0, 00001011703WK4, 00001011712WK5, 00001012286WK9, 00001012453WK5, 00001013134WK0, 00001014310WK5, 00001014936WK7, 00001016147WK9
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by letter dated March 7, 2008. Firm initiated recall is ongoing.
REASON
Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patient safety. Occasional generator software errors may cause light X-ray Images with reported mAs readings higher than was actually exposed to the patient using the overhead X-ray tube. The mAs readings reported from the system could be up to ten times higher than what was actually exposed to the patient. Occurrence is limited to the first exposure after the focal spot is switched from small to large. The generator incorrectly applies the small filament limit to the large focal spot, which can cause the large focal spot to produce less current. Subsequent large focal spot exposures will not exhibit this issue.
VOLUME OF PRODUCT IN COMMERCE
454 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
IsoMed Refill Kit, Model 8553, is intended for use in refilling Medtronic IsoMed pumps. Contents: Two 22-gauge needles, extension tubing set with y-connector and clamp, Filter, 10-ml syringe, 60-ml lidded syringe, Fenestrated drape, Template; Product is packaged in a sterile container, Recall # Z-1903-2008
CODE
Lot 60538731, Use by Date is May 10, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, either by personal visits, or telephone, beginning February 4, 2008.
Manufacturer: B. Braun Medical, Inc., Allentown, PA. Firm initiated recall is complete.
REASON
Medtronic is retrieving all unused packages of ISOMED Refill Kit Model 8553, Lot 60538731. This lot of product was released using incorrect endotoxin specification limits. Endotoxin contamination can potentially lead to fever, malaise, respiratory distress, septic shock, and death.
VOLUME OF PRODUCT IN COMMERCE
1,982 units
DISTRIBUTION
Nationwide, Argentina, Australia, and Hong Kong
___________________________________
PRODUCT
CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher, Recall # Z-2056-2008
CODE
Versions 1.5.2, with system numbers (all preceded by C0) 095, 142, 058, 106, 061, 056, 128, 129, 079, 088, 116, 151, 139, 047, 070, 072, 133, 112, 149, 078, 137, 025, 098, 092, 045, 144, 124, 160, 044, 126, 123, 111, 055, 062, 074, 068, 059, 052, 103, 132, 100, 150, 051, 094, 119, 034, 146, 153, 064, 155, 037, 114, 046, 063, 097, 143, 067, 131, 042, 048, 090, 091, 122, 159, 022, 109, 099, 135, 036, 134, 127, 158, 057, 069, 030, 118, 108, 152, 136, 049, 102, 080, 101, 141, 071, 087, 140, 107, 145, 148, 120, 023, 147, 089, 038, 041, 065, 138, 060, 113, 110, 130, 043, 125, 105, 093, 117, 032, 066
RECALLING FIRM/MANUFACTURER
Accuray, Inc., Sunnyvale, CA, by letter on April 16, 2008. Firm initiated recall is ongoing.
REASON
Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be used by users.
VOLUME OF PRODUCT IN COMMERCE
109 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 5 x 30mm, Non-winged, Catalog # LG-PR0530, Recall # Z-2060-2008;
b) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 5 x 35mm, Non-winged, Catalog # LG-PR0535, Recall # Z-2061-2008;
c) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 5 x 45mm, Non-winged, Catalog # LG-PR0545, Recall # Z-2062-2008;
d) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 6 x 30mm, Non-winged, Catalog # LG-PR0630, Recall # Z-2063-2008;
e) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 6 x 35mm, Non-winged, Catalog # LG-PR0635, Recall # Z-2064-2008;
f) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 6 x 40mm, Non-winged, Catalog # LG-PR0640, Recall # Z-2065-2008;
g) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 6 x 50mm, Non-winged, Catalog # LG-PR0650, Recall # Z-2066-2008;
h) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 7 x 35mm, Non-winged, Catalog # LG-PR0735 and Screw Size (diameter x
length) 7 x 50mm, Non-winged, Catalog # LG-PR0750, Recall # Z-2067-2008;
i) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 7 x 40mm, Non-winged, Catalog # LG-PR0740, Recall # Z-2068-2008;
j) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 7 x 45mm, Non-winged, Catalog # LG-PR0745, Recall # Z-2069-2008;
k) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 5 x 35mm, Winged, Catalog # LG-PW0535; Recall # Z-2070-2008;
l) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 5 x 40mm, Winged, Catalog # LG-PW0540, Recall # Z-2071-2008;
m) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 5 x 45mm, Winged, Catalog # LG-PW0545, Recall # Z-2072-2008;
n) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 6 x 35mm, Winged, Catalog # LG-PW0635 and Screw Size (diameter x
length) 6 x 55mm, Winged, Catalog # LG-PW0655, Recall # Z-2073-2008;
o) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 6 x 40mm, Winged, Catalog # LG-PW0640, Recall # Z-2074-2008;
p) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 6 x 45mm, Winged, Catalog # LG-PW0645, Recall # Z-2075-2008;
q) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 7 x 35mm, Winged, Catalog # LG-PW0735, Recall # Z-2076-2008;
r) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 7 x 40mm, Winged, Catalog # LG-PW0740, Recall # Z-2077-2008;
s) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x
length) 7 x 45mm, Winged, Catalog # LG-PW0745, Recall # Z-2078-2008
CODE
Catalog # only
RECALLING FIRM/MANUFACTURER
Allez Spine, LLC, Irvine, CA, by telephone on November 8, 2007. Firm initiated recall is complete.
REASON
This recall was initiated after Internal Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and 7 showed a potential of partial displacement of screw shank when used in combination with the single piece locking nuts. This partial displacement of the screw shank could finally lead to total separation and failure of the construct.
VOLUME OF PRODUCT IN COMMERCE
625 units
DISTRIBUTION
AZ, CA, CO and UT
___________________________________
PRODUCT
Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; # 13 with posts, low friction lon treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components, Catalog No. 711-4513L, Recall # Z-2079-2008
CODE
Lot: K04S174
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on March 18, 2005. Firm initiated recall is complete.
REASON
Component labeled and laser marked as a Left, was in fact a Right component.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Internationally
___________________________________
PRODUCT
Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures; Catalog Number: 4940-9-810, Recall # Z-2080-2008
CODE
Lot Codes: H11883, H13813, H17174, H18891, K01047, K03042, K05896
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on August 17, 2005. Firm initiated recall is complete.
REASON
The pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.
VOLUME OF PRODUCT IN COMMERCE
105 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
VariSource® CT/MR Ring & Tandem Applicator Set, catalog # AL13017000, containing 32mm titanium ring applicators, each identified as part numbers AL07362000, AL07363000, and AL07364000, Recall # Z-2081-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems, Inc., Charlottesville, VA, by letter on March 12, 2008.
Manufacturer: Varian Medical Systems U.K. Ltd., Crawley, United Kingdom. Firm initiated recall is ongoing.
REASON
Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment.
VOLUME OF PRODUCT IN COMMERCE
120 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device
is indicated for degeneration, deformity, or trauma of both the tibiotalar and
talocalcaneal articulations in the hindfoot, Recall # Z-2082-2008;
b) Hind Foot Fusion Nail, 11.5mm X 25mm Left, REF 71701125L. The device is
indicated for degeneration, deformity, or trauma of both the tibiotalar and
talocalcaneal articulations in the hindfoot, Recall # Z-2083-2008;
c) TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Left, REF 71701120L. The
device is indicated for degeneration, deformity, or trauma of both the tibiotalar and
talocalcaneal articulations in the hindfoot, Recall # Z-2084-2008;
d) TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The device
is indicated for degeneration, deformity, or trauma of both the tibiotalar and
talocalcaneal articulations in the hindfoot, Recall # Z-2085-2008;
e) TRIGEN Hind Foot Fusion Nail, 10mm X 16mm Left, REF 71701016L. The device
is indicated for degeneration, deformity, or trauma of both the tibiotalar and
talocalcaneal articulations in the hindfoot, Recall # Z-2086-2008;
f) TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Right, REF 71701120R. The
device is indicated for degeneration, deformity, or trauma of both the tibiotalar and
talocalcaneal articulations in the hindfoot, Recall # Z-2087-2008;
g) TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Right, REF 71701125R. The
device is indicated for degeneration, deformity, or trauma of both the tibiotalar and
talocalcaneal articulations in the hindfoot, Recall # Z-2088-2008
CODE
a) Lot No. 07FM16322, exp. 06/2017;
b) Lot Nos.: 07GM00339, exp. 07/2017; 07EM23987, exp. 05/2017; 07EM23988,
exp. 05/2017; 07EM23990, exp. 05/2017; 07EM23989, exp. 05/2017;
c) Lot Nos.: 07GM00331, exp. 07/2017; 07EM19430, exp. 05/2017; 07EM19433,
exp. 05/2017; 07EM19429, exp. 05/2017; 07EM19436, exp. 05/2017; 07EM19438,
exp. 05/2017;
d) Lot No. 07EM23985, exp. 05/2017;
e) Lot Nos.: 07FM05443, exp. 06/2017; 07FM05447, exp. 06/2017; 07FM05444, exp.
06/2017; 07FM05445, exp. 06/2017; 07FM05446, exp. 06/2017;
f) Lot Nos.: 07EM23986, exp. 05/2017; 07EM14998, exp. 05/2017; 07EM15191, exp.
05/2017; 07EM15186, exp. 05/2017; 07EM15187, exp. 05/2017; 07EM15190, exp.
05/2017; 07EM15189, exp. 05/2017; 07EM11027, exp. 05/2017; 07EM11030, exp.
05/2017; 07EM11033, exp. 05/2017; 07EM11052, exp. 05/2017; 07EM11048, exp.
05/2017; 07DM21935, exp. 04/2017; 07DM20072, exp. 04/2017; 07DM20074, exp.
04/2017; 07DM21934, exp. 04/2017;
g) Lot Nos.: 07EM17278, exp. 05/2017; 07DM21938, exp. 04/2017
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Memphis, TN, by letter on April 22, 2008 and e-mail on April 22, and April 23, 2008. Firm initiated recall is complete.
REASON
One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory.
VOLUME OF PRODUCT IN COMMERCE
265 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog number 55-300, packaged in a PET tray, Recall # Z-2089-2008
CODE
All products distributed between 04/07/2005 through 04/28/2006, Lot numbers (batch numbers are the same as lot numbers, without preceding letter): c45301, c50101, c50202, c50203, c50204, c50205, c50301, c50302, c50303, c50304, c50305, c50401, c50402, c50403, c50404, c50405, c50406, c50501, c50502, c50503, c50601, c50602, c50701, c50702, c50703, c50704, c50801, c50802, c50803, c50804, c50805, c50901, c50902, c50903, c50904, c51001, c51002, c51003, c51101, c51102, c51201, c51202, c51301, c51302, c51303, c51304, c51305, c51401, c51402, c51403, c51404, c51405, c51601, c51602, c51701, c51702, c51801, c51802, c51803, c51804, c52101, c52201, c52202, c52203, c52401, c52402, c52403, c52501, c52502, c52503, c52504, c52505, c52601, c52602, c52603, c52701, c52702, c52703, c52704, c52801, c52802, c52901, c52902, c52903, c52904, c53001, c53003, c53103, and c53801
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Cupertino, Corp., Cupertino, CA, by letters.
Manufacturer: Boston Scientific Corp, Natick, MA. Firm initiated recall is complete.
REASON
Tip may detach from stent delivery system.
VOLUME OF PRODUCT IN COMMERCE
1,326 units
DISTRIBUTION
Internationally
___________________________________
PRODUCT
COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients for disease progress or response to therapy, Recall # Z-2090-2008
CODE
Lot Numbers: IKPS1 884 - 100 test size, exp. 5/30/2008; IKPS2 864 - 200 test size, exp. 5/30/2008; IKPS5 862 - 500 test size, exp. 5/30/2008; IKPSX 854 - 1000 test size, exp. 5/30/2008
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions Diagnostics, Los Angeles, CA, by Customer Bulletin on May 21, 2008. Firm initiated recall is ongoing.
REASON
The Coat-A-Count PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low bias, which is evident when comparing results with other methods, including the IMMULITE PSA kits. Coat-A-Count PSA IRMA results are, for example, approximately 20% lower when compared to results obtained with the IMMULITE 2000 Third Generation PSA assay (L2KUP).
VOLUME OF PRODUCT IN COMMERCE
64 kits
DISTRIBUTION
CA, FL, IL, IN, MD, MI, Bolivia, Chile, Egypt, Cyprus, Korea, Phillippines, Taiwan, Uruguay
___________________________________
PRODUCT
Radiation therapy system - Coherence AG Therapist Part number 5863506 and
Therapist system Part number 7339125, equipped with a Coherence Therapist
RTT2.1 or Primeview 3i R2.1. This is a medical charged particle radiation therapy
system, part of the firm's beam limiting device/accessory. The product provides data
processing, and the SYNGO standard medical imaging platform to provide
comprehensive oncology workflow solutions for radiation therapy, Recall # Z-2095-
2008;
b) Radiation therapy system - Coherence Impression Therapist System equipped with a
Coherence Therapist RTT2.1 or Primeview 3i R2.1 part number 7341410. Medical
charged particle Radiation therapy system, part of the firm's beam limiting
device/accessory. The product provides data processing, and the SYNGO standard
medical imaging platform to provide comprehensive oncology workflow solutions
for radiation therapy, Recall # Z-2096-2008;
c) Radiation therapy system - PRIMEVIEW 3i System equipped with a Coherence
Therapist RTT2.1 or Primeview 3i R2.1, part number 7341428. Medical charged
particle Radiation therapy system, part of the firm's beam limiting device/accessory.
The product provides data processing, and the SYNGO standard medical imaging
platform to provide comprehensive oncology workflow solutions for radiation
therapy, Recall # Z-2097-2008;
d) Radiation therapy system - AG Therapist 3rd party V&R equipped with Coherence
Therapist RTT2.1 or Primeview 3i R2.1, part number 7345411. Medical charged
particle Radiation therapy system, part of the firm's beam limiting device/accessory.
The product provides data processing, and the SYNGO standard medical imaging
platform to provide comprehensive oncology workflow solutions for radiation therapy,
Recall # Z-2098-2008;
e) Radiation therapy system - Impression Therapist 3rd party V&R equipped with
Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7345429. Medical
charged particle Radiation therapy system, part of the firm's beam limiting
device/accessory. The product provides data processing, and the SYNGO standard
medical imaging platform to provide comprehensive oncology workflow solutions for
radiation therapy, Recall # Z-2099-2008;
f) Radiation therapy system - Syngo Based WS for 3rd party V&R equipped with
Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7345437. Medical
charged particle Radiation therapy system, part of the firm's beam limiting
device/accessory. The product provides data processing, and the SYNGO standard
medical imaging platform to provide comprehensive oncology workflow solutions for
radiation therapy, Recall # Z-2100-2008;
g) Radiation therapy system - Coherence Therapist 2.0 equipped with Coherence
Therapist RTT2.1 or Primeview 3i R2.1, part number 8139839. Medical charged
particle Radiation therapy system, part of the firm's beam limiting device/accessory.
The product provides data processing, and the SYNGO standard medical imaging
platform to provide comprehensive oncology workflow solutions for radiation therapy,
Recall # Z-2101-2008;
h) Radiation therapy system - PRIMEVIEW 3i System 2.0 equipped with Coherence
Therapist RTT2.1 or Primeview 3i R2.1, part number 8139847. Medical charged
particle Radiation therapy system, part of the firm's beam limiting device/accessory.
The product provides data processing, and the SYNGO standard medical imaging
platform to provide comprehensive oncology workflow solutions for radiation therapy,
Recall # Z-2102-2008;
i) Radiation therapy system - Coherence Therapist System 2.1 equipped with Coherence
Therapist RTT2.1 or Primeview 3i R2.1, part number 8147667. Medical charged
particle Radiation therapy system, part of the firm's beam limiting device/accessory.
The product provides data processing, and the SYNGO standard medical imaging
platform to provide comprehensive oncology workflow solutions for radiation therapy.
Applies only to those parts used with the following devices identified in the product
descriptions, Recall # Z-2103-2008;
j) Radiation therapy system - PRIMEVIEW 3i System 2.1 equipped with Coherence
Therapist RTT2.1 or Primeview 3i R2.1, part number 8147675. Medical charged
particle Radiation therapy system, part of the firm's beam limiting device/accessory.
The product provides data processing, and the SYNGO standard medical imaging
platform to provide comprehensive oncology workflow solutions for radiation therapy.
Medical Linear accelerators equipped with Coherence Therapist RTT2.1 or Primeview
3i R2.1 Software Numbers 8146503, 8149119, and 8163318. Applies only to those
parts used with the following devices identified in the product descriptions,
Recall # Z-2104-2008
CODE
Software Numbers 8146503, 8149119, and 8163318. Applies only to those parts used with the devices identified in the product descriptions.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter on May 15, 2008. Firm initiated recall is ongoing.
REASON
Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
VOLUME OF PRODUCT IN COMMERCE
491 units
DISTRIBUTION
Distribution information pending from firm.
___________________________________
PRODUCT
a) GE 1.5T and 3.0T Signa® HDx MR System Model Numbers: 5127452, 2377062-61,
and 2395001-2. Indicated for use as a diagnostic imaging device to produce axial
sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic
images of the internal structures and organs of the entire body, including, but not
limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate,
blood vessels, and musculoskeletal regions of the body, Recall # Z-2210-2008;
b) GE Signa® Excite 1.5T MR System, GE Signa® Excite 3.0T MR System. Model
Numbers 5107849, 5107849-2, M3000PT, and M3000PW. Indicated for use as a
diagnostic imaging device to produce axial sagittal, coronal and oblique images,
spectroscopic images, and/or spectra, dynamic images of the internal structures and
organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast,
heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of
the body, Recall # Z-2211-2008
CODE
a) 00000HDMR20228 00000276057MR7 00000275160MR0 000000HDMR2544 00000HDMR10417 00000HDMR10094 00000274383MR9 00000273832MR6 00000274385MR4 00000276073MR4 00000274359MR9 00000HDMR10273 00000273119MR8 00000DDDM10670 00000HDMR20073 00000HDMR10739 000000HDMR2451 000000HDMR2335 00000HDMR20189 000000HDMR1004 00000HDMR10489 00000HDMR10291 00000HDMR20151 00000HDMR20061 00000HDMR10743 000000HDMR2528 000000HDMR2976 00000HDMR20044 000000HDMR2773 00000HDMR20294 00000HDMR20059 00000HDMR10418 00000HDMR10831 00000HDMR20036 00000HDMR20056 Model No. 2377062-61 00000008376YR6 00000007126YR6 00000007551YR5 00000007555YR6 00000006690YR2 00000007518YR4 00000008525YR8 00000005222YR5 00000007134YR0 00000008354YR3 00000005989YR9 00000007107YR6 00000008100YR0 00000007594YR5 00000006710YR8 00000008103YR4 00000007092YR0 00000007503YR6 00000007574YR7 00000006754YR6 00000007542YR4 00000008116YR6 00000008522YR5 00000006685YR2 00000007105YR0 00000008564YR7 00000005974YR1 00000005545YR9 00000006705YR8 00000006600YR1 00000007585YR3 00000005532YR7 00000008549YR8 00000007533YR3 00000007498YR9 00000005231YR6 00000006583YR9 00000005216YR7 00000007554YR9 00000009031YR6 00000006708YR2 00000007117YR5 00000007864YR2 00000007866YR7 00000007514YR3 00000008342YR8 00000005546YR7 00000007892YR3 00000007865YR9 00000006556YR5 00000006660YR5 00000007862YR6 00000009421YR9 00000007556YR4 00000008378YR2 00000008539YR9 00000006656YR3 00000005536YR8 00000008115YR8 00000008335YR2 00000052299YR0 00000006727YR2 00000006726YR4 00000007572YR1 Model No, 2395001-2 00000280673MR5 00000278397MR5 00000277211MR9 00000276434MR8 00000275968MR6 00000278549MR1 00000280781MR6 00000276265MR6 00000275046MR1 00000283745MR8 00000284233MR4 00000275648MR4 00000280000MR1 00000279068MR1 00000275967MR8 00000274744MR2 00000276266MR4 00000280001MR9 00000278851MR1 00000275647MR6 00000281340MR0 00000275465MR3 00000282549MR5
b) 00000262460MR9 00000270245MR4 00000260692MR9 00000269581MR5 00000268123MR7 00000277574MR0 00000267973MR6 00000280302MR1 00000262803MR0 00000270974MR9 00000273229MR5 00000277190MR5 00000277189MR7 00000279752MR0 00000261198MR6 00000272433MR4 00000269437MR0 00000265177MR6 00000264407MR8 00000265173MR5 00000274998MR4 00000268011MR4 00000270383MR3 00000262459MR1 00000269326MR5 00000261064MR0 00000271248MR7 00000263970MR6 00000276409MR0 00000274835MR8 00000278722MR4 00000271120MR8 00000262456MR7 00000273459MR8 00000266821MR8 00000266071MR0 00000276491MR8 00000266066MR0 00000265061MR2 00000266754MR1 00000271234MR7 00000266343MR3 00000273365MR7 00000262299MR1 00000263879MR9 00000262793MR3 00000273341MR8 00000266822MR6 00000269340MR6 00000273230MR3 00000262800MR6 00000261678MR7 00000271246MR1 00000280388MR0 00000261205MR9 00000262666MR1 00000262673MR7 00000260480MR9 00000276591MR5 00000279460MR0 00000272533MR1 00000263974MR8 00000262667MR9 00000261066MR5 00000271124MR0 00000277955MR1 2333 00000272072MR0 00000261069MR9 00000264087MR6 00000267322MR6 00000274839MR0 00000265005MR9 00000275642MR7 00000270466MR6 00000275086MR7 00000261061MR6 00000275845MR6 00000272076MR1 00000269435MR4 00000270387MR4 00000268518MR8 00000268477MR7 00000268515MR4 00000269575MR7 00000272968MR9 00000270026MR8 00000272969MR7 00000272070MR4 00000268692MR1 00000271662MR9 00000268417MR3 00000270467MR4 00000272536MR4 00000273529MR8 00000279146MR5 00000275668MR 00000260651MR5 Model No, 5107849-2 00000279077MR2 00000282686MR5 00000283386MR1 00000283076MR8 00000279423MR8 00000278623MR4 00000278626MR7 00000279921MR1 00000276633MR5 00000273541MR3 00000274170MR0 00000274930MR7 00000281703MR9 00000281443MR2 00000281019MR0 00000275936MR3 00000279713MR2 00000273267MR5 00000273266MR7 Model No. M3000PT 00000266842MR4 00000266160MR1 00000271322MR0 00000275009MR9 00000268302MR7 00000263655MR3 00000264783MR2 00000266194MR0 00000267528MR8 00000026005MR8 00000266156MR9 00000265852MR4 00000267533MR8 000267533MR8ZZ 00000265968MR8 00000267529MR6 00000267527MR0 00000266690MR7 00000264643MR8 00000267618MR7 00000268837MR2 00000270528MR3 00000270097MR9 00000268301MR9 00000269332MR3 00000267860MR5 Model No. M3000PW 00000266270MR8 00000250462MR9 00000263921MR9
RECALLING FIRM/MANUFACTURER
GE Medical Systems LLC, Waukesha, WI, by letter dated September 14, 2007. Firm initiated recall is ongoing.
REASON
A software issue that may result in misregistration of functional and anatomical images associated with the 3.0T BrainwaveRT fMRI Application on the 3.0T Signa HDx scanner.
VOLUME OF PRODUCT IN COMMERCE
269 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology, Recall # Z-2229-2008
CODE
Serial Numbers: P002-B-070316-01, P002-B-070423-01, P002-B-070531-01, P002-B-070629-01, P002-B-070712-0l, P002-B-070718-01, P002-B-070910-01, P002-B-070911-01, P002-B-071015-01, P002-B-080107-01, P002-B-080108-01, P002-B-080207-01, and P002-B-080307-01
RECALLING FIRM/MANUFACTURER
Naviscan PET Systems, San Diego, CA, by letter on June 19, 2008. Firm initiated recall is ongoing.
REASON
This field correction is being initiated as a result of the firm's investigation into a report from a user indicating that the motorized compression exceeded 25 pounds of compression force during the pre-scan positioning of the patient. The investigation identified that a secondary fault protection did not perform as expected.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Siemens brand Ultrasound Transducer 17L5HD used with ACUSON Sequoia Ultrasound System; Model Number(s): 10035724, used with System Models: 08245875, 08246951, 08255412, 08255413, 08267697, 08269627, 10038241, 10038242, 10040724, 10040725, 10041008; Product is manufactured and distributed by The 17L5 transducer is intended for breast and small body parts imaging, Recall # Z-2230-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letters on June 6, 2008. Firm initiated recall is ongoing.
REASON
The product assembly can cause a failure of the transducer which results in a double and/or overlapped image which may ultimately result in misleading or false information, inability to accurately diagnose, incorrect positioning/locating/insertion of the biopsy needle and/or an interruption during the biopsy procedure.
VOLUME OF PRODUCT IN COMMERCE
388 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, Part #7-201738-01; v2.20DB, Part #7-201738-02; v2.60, Part #7-203715-01; v3.10, Part #7-203715-02; 3.11, Part 7-203715-03; and 3.12. The Abbott ARCHITECT cSystem is designed to perform automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations, Recall # Z-2231-2008
CODE
Version 2.20, List #05F48-13; Version 2.20DB, List #05F48-14; Version 2.60, List #05F48-17; Version 3.10, List #05F48-18; Version 3.11, List #05F48-20, and Version 3.12, List #05F48-21
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on May 23, 2008. Firm initiated recall is ongoing.
REASON
Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample.
VOLUME OF PRODUCT IN COMMERCE
2,378 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
a) Axis Gamma Camera, Scintillation (gamma) camera. Model Numbers: 210714,
210880 and 211037 Part Numbers: 4535 665 13461, or N210714 Axis System,
3/8" Crystals 4535 665 16601, or N210880 Axis System 3/4" Crystals 4535 665
12921, or N211037 Axis System 3/8 Precision 4535 665 13501, or N211039 Axis
System 3/4 Precision 4535 679 46301, or N211280 Axis System 3/8 Precision 4535
671 67421, or N211282 Axis System 3/4 Precision (Note: Due to a part number
scheme change at the firm, either number is representative of the identified system),
Recall # Z-1510-2008;
b) Irix Gamma Camera, Scintillation (gamma) camera. Model Numbers: 210857 and
210881. 4535 679 46991, or N210857 Irix System, 3/8" Crystal 4535 665 13551, or
N210881 Irix System 3/4" Crystals 4535 679 46981, or N211038 Irix System 3/8
Precision 4535 665 13571, or N211040 Irix System 3/4 Precision (Note: Due to a
part number scheme change at the firm, either number is representative of the
identified system), Recall # Z-1511-2008;
c) Rotate Motion Shunt Resistor Kit, Scintillation (gamma) camera, Recall # Z-1512-
2008
CODE
a) and b) All units installed from April 1, 2000 - November 30, 2007;
c) Lot Numbers: 4535 664 01241 and N753360
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland), Inc., Cleveland, OH, by letter on January 30, 2008. Firm initiated recall is ongoing.
REASON
Resistor Failure: The Rotate Motion Shunt Resistor may overheat and results in the appearance of smoke, a burning smell, and an electronic stop condition, which will disable the gamma camera rotate motion and all other motions.
VOLUME OF PRODUCT IN COMMERCE
Undetermined
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Harleco Brand Ethanol Standard, 1.0 mg/ml 1.0 mg Ethanol in 1 ml 10 ampules; Each ampule contains approximately 1.1 ml to facilitate the removal of 1.0 ml, Item number 68991/95, Recall # Z-1607-2008
CODE
Lot number 7285 Expiration Date: April 30, 2010.
RECALLING FIRM/MANUFACTURER
EMD Chemicals, Inc., Gibbstown, NJ, by e-mail on March 27, 2008 and letters on April 3, 2008. Firm initiated recall is ongoing.
REASON
EMD Chemicals received 1 customer complaint regarding 2 ampules measuring 2.0 mg/ml found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.
VOLUME OF PRODUCT IN COMMERCE
112 cases/10 ampules per case
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The test cassettes are for use with the LDX analyzer; Catalog #12-807, Recall # Z-2457-2008
CODE
Lot # C17-6434
RECALLING FIRM/MANUFACTURER
Cholestech, Corp., Hayward, CA, by letter dated August 9, 2005. Firm initiated recall is complete.
REASON
Test results are high, outside of control material upper limit specification . Results could be as high as 15%.
VOLUME OF PRODUCT IN COMMERCE
2,190 cassettes
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR OCTOBER 1, 2008

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