March 10, 1999 99-10
CODE
Not coded. All products.
MANUFACTURER
5 Star Distributors, Dearborn, Michigan.
RECALLED BY
Manufacturer, by visit on or about November 12, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Michigan.
QUANTITY
Less than 25 pounds were distributed.
REASON
Product contained an unapproved color additive.
________
PRODUCT
Reduced Fat Chocolate Chip Cookie Dough, in 18 ounce chub
containers, under the following labels: Superbrand, Kroger, and
Weis. Recall #F-220-9.
CODE
Expiration dates of 09MAY99 or earlier for the Kroger and Weis
brands and expiration date of 06DEC98 for the Superbrand
label.
MANUFACTURER
Earth Grains Refrigerated Dough Products, Inc., Carrollton,
Texas.
RECALLED BY
Earth Grains Refrigerated Dough Products, Inc., St. Louis,
Missouri, by letter faxed on January 26 & 27, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION
Tennessee, Kentucky, Pennsylvania, Virginia, Ohio, California.
QUANTITY
4,608 cases were distributed.
REASON
Product contains undeclared dairy ingredients.
________
PRODUCT
Shaw's Cinnamon Apple Sauce, in 25 ounce glass jars.
Recall #F-221-9.
CODE
11471/WJL13 (additional letters A-Z follows the number 3).
MANUFACTURER
Knouse Foods, Inc., Chambersburg, Pennsylvania.
RECALLED BY
Shaw's Supermarket, Inc., East Bridgewater, Massachusetts, by
E-mail and by press release on February 4, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Connecticut, Massachusetts, Rhode Island, New Hampshire, Maine,
Vermont.
QUANTITY
148 cases (5 jars per case) were distributed.
REASON
Product may contain small pieces of glass.
________
PRODUCT
Chamon Smoked Salmon Cheese Spread, packaged in 5 pound plastic
containers. Recall #F-222-9.
CODE
Production codes from December 24, 1998 to February 4, 1999.
836008, 836503, 900804, 901403, 902505, 902804.
MANUFACTURER
JP Spreads, Inc., Winthrop, Maine.
RECALLED BY
Manufacturer, by telephone and by letter on February 4, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION
Massachusetts, New York, New Jersey, Pennsylvania, Virginia,
North Carolina.
QUANTITY
Firm estimated that less than 1,330 pounds of product remained on
market at time of recall initiation.
REASON
Product contains undeclared FD&C Yellow No. 5.
CODE
904029, 929019, 921019, 915019, 928128, 917128, 916128, 910128, 909128, 908128, 902128, 901128, 927118, 925118, 920118, 918118, 912118, 911118, 906118, 905118, 904118, 903118, 930108, 929108, 928108, 921108, 908108, 907108, 906108, 902108, 901108, 930098, 929098, 924098, 923098, 922098, 918098, 917098, 916098, 910098, 909098, 927088, 920088, 919088, 918088, 914088, 913088, 911088, 906088, 905088.
MANUFACTURER
Idaho Candy Company, Boise, Idaho.
RECALLED BY
Manufacturer, by letter dated February 22, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Idaho, Washington state, Oregon, North Carolina, Nevada, Utah,
Wyoming, Montana, North Dakota, Arkansas and Colorado.
QUANTITY
Approximately 774,840 bars were distributed.
REASON
Product is unfit for food due to containing small pieces of
wood.
________
PRODUCT
Low Moisture Part Skim Mozzarella Cheese, in approximate 6 pound
loaf. Recall #F-223-9.
CODE
"06 44 11 08 1998G" (on loaves) and "208312" (on cases).
MANUFACTURER
Beatrice Cheese, Inc., Gustine, California.
RECALLED BY
Beatrice Cheese, Inc., Waukesha, Wisconsin, by verbal
communication on December 16, 1998, and by letter.
Firm-initiated recall ongoing.
DISTRIBUTION
California.
QUANTITY
143,660 pounds were distributed.
REASON
Product is unfit for food due to containing small pieces of
metal.
Oxygen, USP, Rx, compressed, in high pressure cylinders, E, D, and A size; Oxygen, USP, Rx, liquefied, in GP-4500 and GP-5500 vessels; Medical Air, USP, Rx, compressed, in high pressure cylinders, Size 233. Recall #D-129/131-9.
CODE
Medical Air USP: 18L981 18L982 01M981 02M981 Medical Oxygen USP: 05L981 05L982 05L983 06L981 18L981 18L982 01M981 02M981 02M982 04M981 04M982 07M981 07M982 07M983 07M984 07M985 07M986 08M981 08M982.
MANUFACTURER
Red Ball Oxygen Co., Inc., Shreveport, Louisiana.
RECALLED BY
Manufacturer, by fax followed by letter dated December 18, 1998,
and telephone. Firm-initiated recall ongoing.
DISTRIBUTION
Arkansas, Louisiana, Texas.
QUANTITY
a) 1,008 cylinders; b) 6 cylinders; c) 2 cylinders were
distributed.
REASON
Current good manufacturing practice deviations including but not
limited to: Lack of documented assay results for purity and
identity and Lack of equipment calibration records.
CODE
Unit Numbers: 17184-0167, 17185-3384, 17185-6919-01,
17185-6919-02, 17185-8528-01.
MANUFACTURER
United Blood Services, McAllen, Texas.
RECALLED BY
Manufacturer, by telephone on January 6, 1999, and by letter on
January 22, 1999. Firm-initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
5 units were distributed.
REASON
Blood products had high platelet counts.
________
PRODUCT
Red Blood Cells. Recall #B-544-9.
CODE
Unit #5066686.
MANUFACTURER
BloodCare, Dallas, Texas.
RECALLED BY
Blood Care, Bedford, Texas, by letter dated October 8, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor whose arm had not been
adequately prepared prior to venipuncture.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-557/558-9.
CODE
Unit #5079884.
MANUFACTURER
BloodCare, Dallas, Texas.
RECALLED BY
Manufacturer, by telephone and fax on July 26, 1998, and by
letters dated August 14, 1998, and November 20, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Texas and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who reported
previously testing positive for hepatitis B.
________
PRODUCT
Red Blood Cells. Recall #B-559-9.
CODE
Unit #9037768.
MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, Oklahoma.
RECALLED BY
Manufacturer, by fax on May 30, 1997. Firm-initiated recall
complete.
DISTRIBUTION
Oklahoma.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Red Blood Cells. Recall #B-560-9.
CODE
Unit #9589271.
MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, Oklahoma.
RECALLED BY
Manufacturer, by telephone on June 24, 1997, or by fax on
September 29, 1997. Firm-initiated recall complete.
DISTRIBUTION
Oklahoma.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
_______
PRODUCT
Platelets. Recall #B-566-9.
CODE
Unit #411571.
MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by telephone on July 17, 1996. Firm-initiated
recall complete.
DISTRIBUTION
Minnesota.
QUANTITY
1 unit was distributed.
REASON
Blood product corresponded to a unit of Red Blood Cells that was
positive for Serratia liquifaciens.
_________
PRODUCT
Red Blood Cells. Recall #B-567-9.
CODE
Unit numbers: 3218643, 5535507, 5535526, 9025398, and
9531766.
MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, Oklahoma.
RECALLED BY
Manufacturer, by telephone on December 3, 1996, by fax on January
24, 1997, and October 30, 1998. Firm-initiated recall
complete.
DISTRIBUTION
Oklahoma, Arkansas, Texas.
QUANTITY
5 units were distributed.
REASON
Blood products corresponded to a unit of single donor platelets
which was positive for Staphylococcus auricularis, or a unit of
pooled platelets which was positive for Enterococcus faecalis.
CODE
Unit #19GJ31326.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by fax on August 22, 1996. Firm-initiated recall
complete.
DISTRIBUTION
Switzerland.
QUANTITY
1 unit was distributed.
REASON
Unit of red blood cells, implicated in a transfusion reaction was
found to be contaminated with Serratia marcescens. Corresponding
blood product was distributed.
________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes Removed;
c) Cryoprecipitate; d) Fresh Frozen Plasma; e) Platelet
Concentrate; f) Recovered Plasma. Recall #B-537/542-9.
CODE
Unit numbers: a) R88058, R88067, R88072, W76310, W76314, W76318, L88758, W76326, R88065, R88070, R88075, R88078, R88093, W76257, H95335, H95339, H95617, H95619, L88753, L88761, H95625, W76288; b) W76292, W76298, W76299, W76302, H95327, H95332; c) W76299, L88758, R88093, H95335, H95339; d) R88058, W76314, W76318, W76326, R88065, R88075, R88078, L88756; e) R88058, R88072, W76310, W76314, W76318, R88075, W76326, R88065, R88070, R88078, H95617, L88753, L88756, L88761, W76288, W76292, H95625; f) W76298, R88067, W76299, R88072, W76302, W76310, L88758, R88070, R88093, W76257, H95327, H95332, H95335, H95339, H95617, H95619, L88753, L88761, W76288, W76292, H95625.
MANUFACTURER
Healthcare Provider Services, Inc., Providence, Rhode Island.
RECALLED BY
Manufacturer, by letters dated November 5, 1998, and December 17,
1998. Firm-initiated recall complete.
DISTRIBUTION
Massachusetts, Rhode Island, Switzerland.
QUANTITY
a) 22 units; b) 6 units; c) 5 units; d) 8 units; e) 17 units;
f) 21 units were distributed.
REASON
Blood products were incorrectly tested for the anti-HIV-1
Antigen.
________
PRODUCT
Autologous Peripheral Blood Stem Cells. Recall #B-555-9.
CODE
Unit #5012743.
MANUFACTURER
BloodCare, Dallas, Texas.
RECALLED BY
Manufacturer, by letter dated October 22, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Autologous blood product tested repeatedly reactive for
anti-HTLV-1/2 Western blot indeterminate was distributed without
a "Biohazard" label.
________
PRODUCT
Platelets. Recall #B-556-9.
CODE
Unit #10515-6735.
MANUFACTURER
United Blood Services, Scottsdale, Arizona.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on August
15, 1996. Firm-initiated recall complete.
DISTRIBUTION
North Dakota.
QUANTITY
1 unit was distributed.
REASON
Blood product was prepared from a unit of whole blood designated
as a difficult collection.
________
PRODUCT
Platelets, Pheresis. Recall #B-561-9.
CODE
Unit numbers: 7357373-AP, 7357373-AP2, 7357373-AP3 (split
product).
MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, Oklahoma.
RECALLED BY
Manufacturer, by fax on September 16, 1997. Firm-initiated
recall complete.
DISTRIBUTION
Oklahoma.
QUANTITY
3 units were distributed.
REASON
Blood products were distributed after the donor reported a post
donation illness.
CODE
Catalog Number and Serial Number: Z-623-9 Catalog Number: 0500CAH Serial Numbers: 13000072 through 13000079 Z-624-9 Catalog Number: 0500CEH Serial Numbers: 13000727 through 13000735 Z-625-9 Catalog Number: 0500EAA Serial Numbers: 01008733, 01313153, 01413992, 02008925, 02401891, 03313332, 0382141, 04009140, 04906080, 05414166, 06009449, 06414255, 07313548, 0782589, 0782643, 08111351, 08313729, 08313748, 08401467, 08414373, 08414377, 0882788, 0882825, 0882915, 09212832, 09414386, 09414418, 0983105, 0983125, 10212900, 10313792, 10414489, 11212995, 1183710, 11907344, 12010360, 12010412, 12111764, 12111770, 12111778 Z-626-9 Catalog Number: 0500FAA Serial Numbers: 13000520, 13000521, 13000523, 13000524, 13000527,13000528 Z-627-9 Catalog Number:0500FEH Serial Numbers: 13000215 through 13000226, 13000230, 13000231 13000233 through 13000237 Z-628-9 Catalog Number: 0501AAY Serial Number: 13000027 Z-629-9 Catalog Number: 0502AAA Serial Numbers: 06901691, 13000258 through 13000263 Z-630-9 Catalog Number: 0502ALH Serial Numbers: 13000140,13000145,13000146 Z-631-9 Catalog Number: 051OAAT Serial Number: 13000022 Z-632-9 Catalog Number: 0511BAT Serial Numbers: 13000373 through 13000381, 13000384, 13000386, 13000387 Z-633-9 Catalog Number: 0511BDT Serial Number: 13000054,13000055,13000056.
MANUFACTURER
Corometrics Medical Systems, Inc., Wallingford, Connecticut.
RECALLED BY
Manufacturer, by telephone on January 18, 1999, and by letter on
January 21, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
California, Connecticut, Florida, Georgia, Louisiana,
Massachusetts, Maryland, Minnesota, Mississippi, Kansas,
Nebraska, New York, Ohio, Tennessee, Texas, Virginia, Washington,
international.
QUANTITY
106 units were distributed.
REASON
The audio alarm may fail to sound.
________
PRODUCT
Model 3000 Nuclear Cameras: a) Model Prism 3000XP;
b) Model Prism 3000 S'. Recall #Z-641/642-9.
CODE
All serial numbers.
MANUFACTURER
Picker International, Inc., Highland Heights, Ohio.
RECALLED BY
Manufacturer, by Mandatory Service Letter #403, dated November
18, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
325 units were distributed.
REASON
Unintended motion of gantry during set up.
________
PRODUCT
Prism XPVT Nuclear Medicine Imaging System: a) AXIS Catalog # 210714; b) AXIS Catalog # 210880; c) AXIS Catalog # 211037; d) AXIS Catalog # 211039; e) IRIX Catalog # 210857; f) IRIX Catalog # 210881; g) IRIX Catalog # 211036; h) IRIX Catalog # 211040. Recall #Z-643/650-9.
CODE
Serial numbers: a) 101 - 171, 173 - 175, 177, 180; b) 101 - 171, 173 - 175, 177; c) 172, 176, 181 - 245, 252, 253, 255; d) 172, 176, 181 - 245, 252, 253, 255; e) 101 - 171, 173 - 175, 177 - 180; f) 101 - 171, 173 - 175, 177 - 180; g) 172, 176, 181 - 234, 252, 253, 255; h) 172, 176, 181 - 245, 252, 253, 255.
MANUFACTURER
Picker International., Inc., Highland Heights, Ohio.
RECALLED BY
Manufacturer, by letter dated December 15, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
63 units were distributed.
REASON
Unexpected camera movement which requires the operator to power
down and reboot with delay in diagnosis.
________
PRODUCT
Nuclear Medical Imaging Systems: a) Prism 1000; b) Prism 1500;
c) Prism 2000; d) Prism 3000. Recall #Z-651/654-9.
CODE
Serial Numbers: a) Prism 1000s - All
Prism 1000XP - All up to and including S/N 973;
b) Prism 1500XP - All up to and including S/N 135;
c) Prism 2000S - All
Prism 2000XP - All up to and including S/N 973;
d) Prism 3000XP, systems S/N 273-424.
MANUFACTURER
Picker International., Inc., Highland Heights, Ohio.
RECALLED BY
Manufacturer, by Mandatory Service Letter #384, dated May 12,
1997. Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
158 units were distributed.
REASON
Software error may result in loss of data requiring patient
re-scan and possible delay in diagnosis.
________
PRODUCT
Nuclear Medical Imaging Systems w/FX and FX 800 Series Computers
and Version 8.3.11 software. Recall #Z-655/656-9.
CODE
All serial numbers.
MANUFACTURER
Picker International, Inc., Highland Heights, Ohio.
RECALLED BY
Manufacturer, by Mandatory Service Letter #404, dated November
17, 1998. Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
70 units were distributed.
REASON
Software error may result in patient misdiagnosis.
_______
PRODUCT
Prism 1500 Nuclear Medical Imaging System, Model 1500XP.
Recall #Z-657-9.
CODE
Serial Numbers: 099, 101 - 151.
MANUFACTURER
Picker International., Inc., Highland Heights, Ohio.
RECALLED BY
Manufacturer, by Mandatory Service Letter #398, dated July 14,
1998. Firm-initiated field correction complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
32 units were distributed.
REASON
Uncommanded, unexpected, linear gantry movement due to
electro- static discharge.
________
PRODUCT
Model 3000 Nuclear Imaging System Cameras: a) Prism 3000XP;
b) 3000S. Recall #Z-658/659-9.
CODE
All serial numbers.
MANUFACTURER
Picker International., Inc., Highland Heights, Ohio.
RECALLED BY
Manufacturer, by Mandatory Service Letter #379, dated February
19, 1997. Firm-initiated field correction complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
70 units were distributed.
REASON
Incorrect head movement and message display due to software
errors.
________
PRODUCT
Edge System Pelvic Array Coil, an accessory to the MRI.
Recall #Z-660-9.
CODE
All serial numbers.
MANUFACTURER
Picker International, Inc., Highland Heights, Ohio.
RECALLED BY
Manufacturer, by Mandatory Service Letter #388, dated October 20,
1997. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
71 units were distributed.
REASON
Excessive patient heating during examination in the Pelvic Array
Coil.
________
PRODUCT
LIFEPAK 12 defibrillator/monitor: designed for both
out-of-hospital and hospital users, automated external
defibrillator (AED) and manual defibrillation therapy, diagnostic
monitoring and extensive data storage capability, Part Numbers:
VLP12-02-000021-24,26,27,29,31,34,35,39,40,42,44,46,50,53,55,57,58,59,62,63,64,65,67,68,69 and 000116. Recall #Z-671-9.
CODE
Selected serial numbers between 11030322 and 11269906.
MANUFACTURER
Medtronic Physio-Control, Redmond, Washington.
RECALLED BY
Manufacturer, by visit beginning on January 13, 1999, and by
letter. Firm-initiated field correction complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
649 units were distributed.
REASON
The placement of incorrect circuit board into the
device resulted in the failure of the device to perform as
intended.
________
PRODUCT
a) Precitrol-A Control Serum and Diluent, Catalog No.
620211/917211,; b) Precitrol-N Control Serum and Diluent, Catalog
No. 620212/917212; c) Precical Calibrator Serum and Diluent,
Catalog No. 620213/917213, d) Bilirubin, Total and Direct,
Catalog No. 123919. Recall #Z-672/675-9.
CODE
Lot Numbers: a) 121033, EXP 09/23/99; b) 121034 EXP 07/25/99;
c) 108615 EXP 02/28/99; 121035 EXP 07/11/99; 253410 EXP 02/06/00;
298017, EXP 05/21/00; 750001, EXP 11/20/00; and 75002, EXP
12/01/00; d)679951, EXP 5/99; and 693365, EXP 8/00.
MANUFACTURER
Roche Diagnostics/Boehringer Mannheim Corporation, Indianapolis,
Indiana; Boehringer Mannheim GmbH, Mannheim, Germany (Catalog
#123919 only).
RECALLED BY
Roche Diagnostics/Boehringer Mannheim Corporation, Indianapolis,
Indiana, by letter on December 7, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 233,000 kits.
REASON
The method for calibration of total bilirubin/DPD results in a
+16% analytical bias compared to the Doumas method.
________
PRODUCT
Lithotripsy System Software EPROMS: a) Software Version LSH V
3.0; b) Software Version V 1.2. Recall #Z-680/681.
CODE
Model: LithoTron System, software versions LSH V 3.0 and LITHO V
1.2 for operation of the following LithoTron instruments: S/N
002, 004, 012, 014, 020, 021, 022, 026, 028, 030, 031, 034, 0045,
046, 047, 048, 050.
MANUFACTURER
HMT High Medical Technologies AG, CH-8280 Kreuzlingen,
Switzerland.
RECALLED BY
HealthTronics, Marietta, Georgia, by software upgrade on November
24, 1998, and by letter dated January 13, 1999. Firm-initiated
field correction ongoing.
DISTRIBUTION
Nebraska, Missouri, Texas, Washington state, Indiana,
Pennsylvania, Florida, Connecticut, California, Tennessee,
Georgia.
QUANTITY
17 LithoTran systems were distributed.
REASON
Software upgrade yielding error messages and complete lock-up of
instrument.
________
PRODUCT
Port-A-Cath P.A.S. Port II Implantable Venous Access, used for
the delivery of drugs, fluids, and nutritional solutions by
infusion or syringe. Recall #Z-682-9.
CODE
All lots.
MANUFACTURER
Sims Deltec, Inc., St. Paul, Minnesota.
RECALLED BY
Manufacturer, by letter on February 16, 1999. Firm-initiated
field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
13,235 units were distributed.
REASON
The portal housings of some of the devices became cracked and
some of the septums in the devices became dislodged.
________
PRODUCT
Olympic Mini Bili-lite, Models 77 & 78. Recall #Z-683/684-9.
CODE
Catalog Numbers: 51477 and 51478, Serial Numbers 1191, 1192,
10052 though 10188 (non-continuous).
MANUFACTURER
Olympic Medical Corp., Seattle, Washington.
RECALLED BY
Manufacturer, by fax on November 19, 1998.
DISTRIBUTION
Nationwide and international.
QUANTITY
138 units were distributed.
REASON
Support springs in Bili-Lites may break causing arm to fall.
________
PRODUCT
Bubble Suction Tubing. Recall #Z-685-9.
CODE
Lot #41AJCM16 EXP 2004-01.
MANUFACTURER
ConMed Corporation, El Paso, Texas.
RECALLED BY
Manufacturer, by fax on February 19, 1999, and by letter dated
February 22, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
North Carolina and Florida.
QUANTITY
12 cases (50 units per case) were distributed.
REASON
Non-sterility.
________
PRODUCT
Beta 90/50 Mobile Imaging Table. Recall #Z-686-9.
CODE
Serial numbers: 2958 and 2965.
MANUFACTURER
Stille Beta, Inc., Akron, Ohio.
RECALLED BY
Manufacturer, by telephone on or about September 15, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Ohio and Florida.
QUANTITY
2 units were distributed.
REASON
Tables were shipped and sold without properly designed final
modifications.
________
PRODUCT
8mm Straight Ratchet Clips, indicated for surgical clamping
during cardiovascular peripheral vascular, and general surgery:
a) Model No. G-8050; b) - Model No. AVD-8000.
Recall Z-687/688-9.
CODE
Lot numbers: a) 96B067, 98B118, C8E032, C8F003; b) E5N013,
96A007, 96C182, 96B065, 96E130 - 96E132, 96G316, 96H446, 97F286,
97K067, 97M206, 98B052, 98C074, C8E012.
MANUFACTURER
Applied Medical Resources, Laguna Hills, California.
RECALLED BY
Manufacturer, by telephone or fax beginning August 6, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
411 units were distributed.
REASON
A non-radiused corner on the ratchet clip could perforate the
pouches, thereby, compromising the sterility of the devices.
________
PRODUCT
Verdict Cocaine Test and Verdict THC/Cocaine Test, intended for
use in the detection of cocaine and/or cocaine metabolites in
human urine: a) Verdict Cocaine 50-Test Pack, Catalog No.
600230, b) Verdict THC/Cocaine 50-Two-Test Pack, Catalog No.
600213. Recall #Z-689/690-9.
CODE
Lot numbers: a) VCOPE-04-7, EXP 5/31/99;
b) VTCPE-02-7, EXP 5/31/97.
MANUFACTURER
MedTox Diagnostics, Burlington, North Carolina.
RECALLED BY
Manufacturer, by letter, followed by telephone on October 16,
1997. Firm-initiated recall complete.
DISTRIBUTION
Alabama, Arizona, California, Florida, Georgia, Iowa, Kentucky,
Louisiana, New York, North Carolina, Ohio, Oklahoma,
Pennsylvania, South Carolina, Texas, Tennessee, Virginia,
Wisconsin, Puerto Rico.
QUANTITY
288 kits were distributed.
REASON
The product can produce false positive cocaine test results.
________
PRODUCT
Kendall Sher-I-Bronch Endobronchial Tubes and VHA Plus
Sher-I-Bronch Endobronchial Tubes, Left and Right Sided, intended
for use in thoracic surgery, bronchospirometry, administration of
endobronchial anesthesia, etc. The tube is indicated for main
stem brochus intubation and allows for selective inflation or
deflation of either lung. Model: Kendall Sher-I-Bronch -10
Catalog Numbers; VHA Plus Sher-I-Bronch- 4 Catalog Numbers. See
Code Information. Recall #Z-699/712-9.
CODE
Kendall's Sher-I-Bronch Endobronchial: CATALOG LOT NO. Description 5-16028 067903 Left Sided, 28 Fr O68551 069429 5-16035 067691 Left Sided, 35 Fr 068385 069422 069431 069865 070339 070749 5-16037 067625 Left Sided, 37 Fr 067685 067688 068387 068555 068586 069003 069005 069860 069861 069867 070341 070869 5-16039 067168 Left Sided, 39 Fr 067174 067684 067687 068548 068553 069423 069424 069862 070338 070340 070343 5-16041 067622 Left Sided, 41 Fr 068550 069006 069859 070346 070867 5-16128 067904 Right Sided, 28 Fr 068386 069194 069426 5-16135 067692 Right Sided, 35 Fr 068388 069425 069431 5-16137 067172 Right Sided, 37 Fr 069004 069427 069433 5-16139 067173 Right Sided, 39 Fr 069863 5-16141 067621 Right Sided, 41 Fr 069428 070345 VHA Plus Label: V5-16035 069421 Left Sided, 35 Fr V5-16037 069002 Left Sided, 37 Fr 070342 070870 V5-16039 067686 Left Sided, 39 Fr 070344 V5-16041 068549 Left Sided, 41 Fr 070868.
MANUFACTURER
Kendall Company, Argyle, New York.
RECALLED BY
Kendall Healthcare, Mansfield, Massachusetts, by letter on
February 5, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
15,731 Kendall units and 895 VHA Plus units were distributed.
REASON
Improper assembly (gap in bonding) of endobronchial tubes may
cause leaking of air/gas.
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PRODUCT
CaverMap Surgical Aid Disposables Kit (Sterile). Part No. 8300.
The UroMed CaverMap Surgical is indicated for use in the
stimulation of the cavernosal nerves, during open prostatectomy
surgical procedures. The kit contains: probe tip, return lead,
and tumescence sensor. Model: CaverMap Surgical Aid Disposables
Kit (sterile). Recall #Z-716-9.
CODE
Part #8300, Lot #JBH9014, EXP 7/14/99.
MANUFACTURER
Uromed Corporation, Norwood, Massachusetts.
RECALLED BY
Manufacturer, by fax on February 11, 1999, followed by telephone
on February 12, 15, 16, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
California, Colorado, New York, Florida, Illinois, Missouri,
Washington state, Tennessee, Canada.
QUANTITY
123 units were distributed.
REASON
Sterility of device is compromised due to tears in the Mylar
Pouch.
CODE
Lot numbers: 5732 and 5738.
MANUFACTURER
Biopool International, Westchester, Pennsylvania.
RECALLED BY
Organon Teknika Corporation, Durham, North Carolina, by letter on
September 18, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, The Netherlands, Canada.
QUANTITY
271 kits containing 25 vials or 100 vials were released for
distribution.
REASON
The test interpretations with these products have proven to be
difficult.
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PRODUCT
ICON Fx hCG Serum-Urine and Urine Test Kits, designed to detect human chorionic gonadotropin (hCG) in urine or serum, as an aid in the early detection of pregnancy: a) Product No. 40005, ICON Fx hCG Serum-Urine - 5 Tests; b) Product No. 40025, ICON Fx hCG Serum-Urine - 25 Tests; c) Product No. 40050, ICON Fx hCG Serum-Urine - 50 Tests; d) Product No. 41025, ICON Fx hCG Urine - 25 Tests. Recall #Z-676/679-9.
CODE
All lots of the above test kits.
MANUFACTURER
Beckman Coulter, Inc., (formerly Smith Kline Diagnostics), Palo
Alto, California.
RECALLED BY
Beckman Coulter, Inc., Brea, California, by letter on January 27,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Puerto Rico.
QUANTITY
8,338 kits were distributed.
REASON
Device gives false negative results in urine samples.
CODE
Lot Number B-18 EXP 8/18/97, C-30 EXP 6/30/98,
T-19 EXP T7-98 (July 1998).
MANUFACTURER
Cargill Inc., Abilene, Texas.
RECALLED BY
ACCO Feeds, Inc. Minneapolis, Minnesota, by telephone on July
31, 1998. Firm-initiated recall complete.
DISTRIBUTION
Texas and New Mexico.
QUANTITY
Firm estimates none remains on the market.
REASON
Lot B-18 contained protein derived from mammalian tissue and was
distributed after the effective date of the regulation and after
its expiration date. Lots C-30 and T-19 were distributed after
their expiry date.
CODE
Lot No. 8-CFY-5051 - Expiration June 2001.
MANUFACTURER
Schering Plough Animal Health Corporation, Elkhorn, Nebraska.
RECALLED BY
Schering Plough Animal Health Corporation, Union, New Jersey, by
telephone on November 5-6, 1998, and by letter dated November 13,
1998. Firm-initiated recall complete.
DISTRIBUTION
Texas, Iowa, Wisconsin, Indiana, California, New York, Nebraska,
Michigan.
QUANTITY
225 units of 12 bottles were distributed.
REASON
Insert had incorrect statement that the product is for use in
dogs and cats. The product is only approved for use in dogs.
Also the wrong NADA number was printed on the insert. Correct
NADA number 132-338.