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U.S. Department of Health and Human Services

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Enforcement Report for June 2, 2004

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.


June 2, 2004
04-22

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Classico Traditional Basil Pesto Sauce and Spread. The
product is sold in 10 oz jars. Recall # F-237-4.
CODE
VA3M08 and VA3M09. This code is stamped on the top of the jars.
RECALLING FIRM/MANUFACTURER
H. J. Heinz Company, L.P., Pittsburgh, PA, by press release and letter on February 20, 2004. Firm initiated recall is complete.
REASON
The product contains undeclared pine nuts. The back label contains an ingredient statement for another product, which did not contain tree nuts.
VOLUME OF PRODUCT IN COMMERCE
4,000 cases.
DISTRIBUTION
Nationwide.

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

****CORRECTIONS****

ENFORCEMENT REPORT 04-06, FEBRUARY 11, 2004, CLASS II - CORRECTION TO CONCURRENCE WITH RECOMMENDATION FOR FIRM INITIATED RECALL: RECALL # B-0594-4 IMMUNE GLOBULIN INTRAVENOUS (HUMAN); GAMMAR-PI.V., 10 gm and RECALL # B-0616-4 IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10%, SOLVENT/DETERGENT TREATED; GAMIMUNE N 10% HAVE BEEN RECLASSIFIED AS MARKET WITHDRAWLS.

_______________________________
PRODUCT
Source Plasma. Recall # B-1344-4.
CODE
Unit numbers 81982783, 81979752, 81971596, 81969128, 81965465, 81962976, 81959853, 81958184, 81948178, and 81946310.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Baton Rouge, by facsimile on May 30, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was previously deferred due to a reactive viral marker test, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1345-4.
CODE
Unit number FE87873.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by letter on January 28, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1346-4.
CODE
Unit number KT26583.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by letter on December 10, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1348-4.
CODE
Unit number L94923.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on January 7, 2004. Firm initiated recall is complete.
REASON
Blood product was collected in a manner that may compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
a) Platelets. Recall # B-1349-4;
b) Fresh Frozen Plasma. Recall # B-1350-4.
CODE
a) Unit numbers T77427 and T77420;
b) Unit numbers K86146 and T77427.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on January 2, 2004. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-1353-4.
CODE
Unit number: L95498.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated December 29, 2003. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1357-4.
CODE
Unit numbers: 0069302, 0069478, 0069923, 0070090, 0075043, 0075384, and 0078620.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wichita Falls, LLC, Wichita Falls, TX, by facsimile on August 28, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1358-4.
CODE
Unit numbers: 113384590, 113386133 .
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, TX, by telephone on October 7, 2003 and by facsimile on October 8, 2003 and December 3, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Units.
DISTRIBUTION
TX, NM, and Switzerland.

_______________________________
PRODUCT
Source Plasma. Recall # B-1365-4.
CODE
Unit numbers: OT242376, OT242158, OT241549, OT240783, OT23522, OT230163, OT229673, OT228886, OT228391, OT226135, OT225565, and OT225229.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Inc., Odessa, TX, by facsimile, dated February 12, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1377-4.
CODE
Unit number 18233-3516.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 17, 2003.
Manufacturer:  Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WY.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1378-4.
CODE
Unit number: 11333-5567.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, TX, by telephone on August 5, 2002. Firm initiated recall is complete.
REASON
Blood product that failed to meet the minimum specification for product volume was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated. Recall # B-1379-4.
CODE
Unit number 16KF40718.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by letter on March 5, 2004. Firm initiated recall is complete.
REASON
Platelets Pheresis with an elevated platelet count based on volume of product collected were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Source Plasma. Recall # B-1380-4.
CODE
Unit numbers 02DOHA1853, 02DOHA2202, 02DOHA2830, 02DOHA3192, and 02DOHA3534.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Dayton, OH, by facsimile on June 5, and 13, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1381-4.
CODE
Unit number 042X83368.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone and letter on January 29 and 30, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-1382-4.
CODE
Unit number 042KP10144.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on February 19, 2004. Firm initiated recall is complete.
REASON
Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Platelets, Pheresis. Recall # B-1383-4.
CODE
Units: 53LF72709 53LT78293 53LF72447 53LF72634 53LF72818 53LF72373 53GK31078 53LT78170 53LF72448 53LF72448 53FG08610 53FG08614 53LT78280 53LT78283 53LF72076 53LF72094 53LF72156 53LF72224 53LF72225 53LF72281 53LF72288 53LF72288 53LF72348 53LF72380 53LF72519 53LF72519 53LF72564 53LF72564 53LF72565 53LF72567 53LF72568 53LF72568 53LF72577 53LF72581 53LF72594 53LF72595 53LF72596 53LF72615 53LF72615 53LF72616 53LF72700 53LF72710 53LF72708 53LF72768 53LF72770 53LF72789 53LF72789 53LF72802 53LF72803 53LF72803 53FG08602 53FG08603 53FG08605 53LT78034 53LT78041 53LT78060 53LT78280 53LT78466 53FG08611 53LF72167 53LF72371 53LF72535 53LF72538 53LF72709 53LF72804 53LF72858 53LF72859 53LF72575 53LT78193 53LF72536 53LF72537 53LF72802 53LT78023 53LT78023 53LT78024 53LT78024 53LT78025 53LT78305 53LT78315 53LF72095 53LF72157 53LF72167 53LF72206 53LF72304 53LF72305 53LF72509 53LF72521 53LF72521 53LF72566 53LF72566 53GK31080 53LF72756 53LF72774 53LF72776 53LF72776 53LT78170 53LT78292 53LF72084 53LF72233 53LF72240 53LF72337 53LF72520 53LF72809 53FG08607 53FG08607 53FG08608 53LT78030 53LF72501 53LF72633 53LF72635 53FG08601 53LF72084 53LF72372 53LF72633 53LF72787 53LT78049 53LT78050 53LF72276 53LF72289 53LF72750 53LF72775 53LF72093 53LF72757 53LF72241. 53LF72501.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD, by letters dated December 24, December 31, 2003 and January 5, 2004. Firm initiated recall is complete.
REASON
Platelets, collected on an instrument that had not been validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
125 units.
DISTRIBUTION
MD and D.C.

_______________________________
PRODUCT
Human Tissue, CryoVein Saphenous Vein. Recall # B-1384-4.
CODE
Tissue 7968766.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter on May 12, 2003. Firm initiated recall is complete.
REASON
Human tissue, procured from a donor who was involved in HIV/Hepatitis high-risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1408-4.
CODE
Unit number FK58831.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation Blood Center, Sacramento, CA, by telephone on March 12, 2003. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1412-4.
CODE
Unit numbers: FK46882 and H63449.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation Blood Center, Sacramento, CA, by telephone on January 29, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from ineligible donors due to decreased hematocrit values, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1413-4.
CODE
Unit number ST228090.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., San Antonio, TX, by facsimile on May 16, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was not properly quarantined after the receipt of post donation information from the donor related to recent ear piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1414-4.
CODE
Unit number 7800029.
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by telephone on July 28, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1415-4.
CODE
Unit number 1246324.
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by facsimile on August 25, 2003. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1418-4.
CODE
Unit number 12810-9428.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone and facsimile on March 19, 2004.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CO, and Switzerland.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1347-4.
CODE
Unit number L95508.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on January 9, 2004. Firm initiated recall is complete.
REASON
Blood product, untested for antibody to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1359-4.
CODE
Unit number: 113384590.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, TX, by telephone on October 7, 2003 and by facsimile on October 8, 2003 and December 3, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
TX, NM, and Switzerland.

_______________________________
PRODUCT
Blood products, collected between May 2001 and April 2003, of the following types:
a) Whole Blood. Recall # B-1385;
b) Whole Blood, Leukocytes Reduced. Recall # B-1386;
c) Red Blood Cells. Recall # B-1387;
d) Red Blood Cells (Apheresis), Recall # B-1388;
e) Red Blood Cells, Irradiated. Recall # B-1389;
f) Red Blood Cells, Leukocytes Reduced. Recall # B-1390;
g) Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # 1391;
h) Red Blood Cells, Washed. Recall # B-1392;
i) Red Blood Cells, Deglycerolized. Recall # B-1393;
j) Red Blood Cells, Frozen. Recall # B-1394;
k) Fresh Frozen Plasma. Recall # B-1395;
l) Fresh Frozen Plasma (Apheresis). Recall # B-1396;
m) Recovered Plasma. Recall # B-1397;
n) Platelets. Recall # B-1398;
o) Platelets, Irradiated. Recall # B-1399;
p) Platelets Pheresis. Recall # B-1400;
q) Platelets Pheresis, Irradiated. Recall # B-1401;
r) Platelets Pheresis, Leukocytes Reduced.
Recall # B-1402;
s) Platelets Pheresis, Leukocytes Reduced Irradiated.
Recall # B-1403;
t) Buffy Coat. Recall # B-1404; (6 units)
u) Cryoprecipitated AHF. Recall # B-1405-4;
v) Platelets, for Further Manufacturing Use.
Recall # B-1406-4.
CODE
Blood products, collected between May 2001 and April 2003, of the above types.
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on August 28, 2003, and letters beginning October 14, 2003. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for human immunodeficiency virus type 1 (HIV-1) antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16,106 units.
DISTRIBUTION
LA, FL, CA, WA, UT, MS, NJ, VA, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1416-4;
b) Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-1417-4.
CODE
a) Unit numbers 5910810, 5911642, 5911017, 5911647,
5911012, 5750808, 5910124, 5910117, 5750807, 5910803,
5910804, 5910809, 5910108, 5910114, 5910120, 5910125,
5910807, 5910896, 5910897, and 5911652;
b) Unit number 5910811.
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by facsimile on October 30, 2003. Firm initiated recall is complete.
REASON
Blood products, that were not leukoreduced within the appropriate time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
FL and NC.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1419-4.
CODE
Unit number 12810-9428.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone and facsimile on March 19, 2004.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CO, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-1420-4.
CODE
Unit numbers: FC95154 and FC93477.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on March 14, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
Minstrel Patient Lift; a non-AC-powered patient lift; model numbers HMB001-US and HMB002-US (with scale). Recall # Z-0970-04.
CODE
All units with and without scales up to and including serial number MPLAT0307W855.
RECALLING FIRM/MANUFACTURER
Arjo, Inc., Roselle, IL, by letters dated April 30, 2004. Firm initiated recall is ongoing.
REASON
The hanger bar may detach from the jib yoke, and the M8 bolt in the foot pedal assembly may come loose, resulting in the patient lift becoming unstable.
VOLUME OF PRODUCT IN COMMERCE
112 units.
DISTRIBUTION
Nationwide.

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Kodak DirectView DR 7100 System, Catalog #133-6049, a
digital radiology system. The major system components are:
operator console; digital imaging capture device; tilting
table with floating top; ceiling-mounted x-ray tube; x-ray
generator timing and distribution unit. Recall # Z-0728-04.
CODE
Serial Numbers affected: 4193-5702, 4193-5704, 4193-5705, 4193-5706, 4193-5708.
RECALLING FIRM/MANUFACTURER
Eastman Kodak Co., Rochester, NY, by Field Representatives on February 20, 2004. Firm initiated recall is complete.
REASON
Defective component in overhead tube support balancer may cause the suspended load to fall.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Amsterdam, China, and Kuwait.

_______________________________
PRODUCT
Xcelera System, image processing, radiological. Recall # Z-0973-04.
CODE
Part numbers: 9896 050 73251XC1.1L1, Software binder: 9896 050 73252XC1.1L1 Software binder + SP2.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letters on April 15, 2004. Firm initiated recall is ongoing.
REASON
Potential for the image data to be erased from the long term archive.
VOLUME OF PRODUCT IN COMMERCE
56 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
VersaRad/Traumex General Radiographic System. Recall # Z-0974-04.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Fischer Imaging Corp., Denver, CO, by letter on April 23, 2004. Firm initiated recall is ongoing.
REASON
Two of the four T-nuts that connect the transverse rail to the "U" arm and transverse rails could fall and cause serious injury.
VOLUME OF PRODUCT IN COMMERCE
138 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Customized Automation Centrifuge, First and Second
Generation. Recall # Z-0975-04.
CODE
First Generation: OPIC0004, HAND0007, HAND0008, HAND0011, HAND0012, U9507151, U9507152, U9507153. Second Generation: 2028, 2030, 2032, 2033, 2034, 2038, 2039, 2040.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter and telephone on May 6, 2004. Firm initiated recall is ongoing.
REASON
Centrifuge loss of containment with potential for injury or exposure to biohazard among lab workers.
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
VariSource High Dose Rate Afterloader, Models 200, 200t, and ID series. Recall # Z-0976-04.
CODE
Config ID/Serial# (Domestic) ACC01220 VS00014 VS00015 VS00016 VS00017 VS00025 VS00028 VS00029 VS00034 VS00036 VS00037 VS00045 VS00047 VS00048 VS00049 VS00050 VS00051 VS00052 VS00053 VS00054 VS00055 VS00058 VS00064 VS00065 VS00066 VS00067 VS00068 VS00070 VS00072 VS00075 VS00076 VS00077 VS00078 VS00082 VS00083 VS00084 VS00085 VS00086 VS00089 VS00095 VS00204 VS00205 VS00207 VS00208 VS00209 VS00210 VS00212 VS00214 VS00215 VS00217 VS00219 VS00220 VS00221 VS00222 VS00223 VS00225 VS00226 VS00227 VS00230 VS00231 VS00232 VS00233 VS00234 VS00236 VS00237 VS00238 VS00243 VS00245 VS00246 VS00251 VS00253 VS00255 VS00256 VS00257 VS00258 VS00261 VS00262 VS00265 VS00266 VS00268 VS00271 VS00276 VS00281 VS00282 VS00283 VS00286 VS00287 VS00288 VS00289 VS00292 VS00296 VS00298 VS00299 VS00300 VS00300-1 VS00302 VS00303 VS00304 VS00305 VS00306 VS00307 VS00309 VS00310 VS00311 VS00314 VS00315 VS00316 VS00317 VS00318 VS00319 VS00320 VS00321 VS00322 VS00323 VS00325 VS00326 VS00327 VS00328 VS00329 VS00330 VS00331 VS00332 VS00333 VS00334 VS00336 VS00337 VS00340 VS00341 VS00342 VS00343 VS00344 VS00345 VS00347 VS00348 VS00349 VS00350 VS00352 VS00355 VS3184177491000 VS3184191051000 VS3184610861000 VSBASSETT VSSTBERNADINESS VSSTOCK.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Charlottesville, VA, by letters on May 4, 2004. Firm initiated recall is ongoing.
REASON
Manufacturer of brachytherapy instrument issued a Customer Technical Bulletin to clarify instructions for use of the radiation treatment medical device by healthcare practitioners. Excessive turning of the hand wheel on VariSource 200, 200t and ID model afterloaders when the active wire is parked can cause the active wire to become dislodged from the shielding.
VOLUME OF PRODUCT IN COMMERCE
249 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Exacta-Mix Valve Set, Primary Valve with Detachable Pump
Tube. Recall # Z-0978-04;
b) Exacta-Mix Valve Set, Secondary Valve Assembly. Recall #
Z-0979-04;
c) Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembly.
Recall # Z-0980-04;
d) Exacta-Mix Valve Set, Six Inlet, Tubing Kit. Recall #
Z-0981-04;
e) Exacta-Mix Valve Set, Primary Valve Assembly. Recall #
Z-0982-04;
f) Exacta-Mix Valve Set, Primary Valve Assembly. Pediatric.
Recall # Z-0983-04;
g) Exacta-Mix Valve Set, Primary Valve Assembly. Recall #
Z-0984-04.
CODE
a) Order No. REF: 69;
b) Order No. REF: 693;
c) Order No. REF: 706;
d) Order No. REF: 706D;
e) Order No. REF: 711E;
f) Order No. REF: 712E;
g) Order No. REF: 713.
RECALLING FIRM/MANUFACTURER
Baxa Corp., Englewood, CO, by telephone, fax, and letter beginning April 30, 2004. Firm initiated recall is ongoing.
REASON
A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
VOLUME OF PRODUCT IN COMMERCE
3,160 cases.
DISTRIBUTION
Nationwide and Internationally.

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Mentor Smooth Round Becker 50 Expander, dome part number 350-DOMPK. Recall # Z-0977-04.
CODE
Lot numbers 269402 and 264358.
RECALLING FIRM/MANUFACTURER
Mentor Texas, Inc., Irving, TX, by letters on December 16, 2003 and February 6, 2004. Firm initiated recall is complete.
REASON
Device was distributed without the dome part accessory.
VOLUME OF PRODUCT IN COMMERCE
51 units.
DISTRIBUTION
Nationwide.

 

END OF ENFORCEMENT REPORT FOR JUNE 2, 2004

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