FDA

Enforcement Report

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


March 10, 1999                                        
99-10

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________
PRODUCT
Turnip Pickle, distributed in unlabeled white plastic pails. Recall #F-218-9.

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.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

________
PRODUCT
Idaho Spud Candy Bars, chocolate covered coconut/center, 1.5 ounces. Recall #F-219-9.

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.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

________
PRODUCT

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.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall #B-543-9.

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.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
Recovered Plasma. Recall #B-470-9.

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.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________
PRODUCT
Corometrics Infant (Apnea) Monitors: Models: 500, 500E, 500EXL, 501, 502, 510, 511. Recall #Z-623/633-9.

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.

________
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.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________
PRODUCT
Sicklequik, an in-vitro diagnostic used as a differential solubility test for Hemoglobin S for diagnosis of sickle cell anemia. Recall #Z-670-9.

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.

________
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.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II

________
PRODUCT
ACCO Beef Maker 28% 250 BOV (AT) Medicated Feed, in 33.3 pound blocks of feed medicated with Lasalocid (125 mg per pound). Recall #V-038-9.

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.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS - CLASS III

________
PRODUCT
Garagen Topical Spray, gentamicin sulfate veterinary with betamethasone valerate, For the treatment of infected superficial lesions in dogs. Recall #V-037-9.

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.

END OF ENFORCEMENT REPORT FOR MARCH 10, 1999. ####