FDA

Enforcement Report

June 30, 1999                                      99-26

RECALLS AND FIELD CORRECTIONS:  CLASS I
________
PRODUCT
Morningland Dairy Raw Milk "Chives Colby" Cheese, packaged in random sizes 
averaging .95 pounds/package.
Recall #F-485-9.
CODE
A259.
MANUFACTURER
Morningland Farm, Inc., Mountain View, Missouri.
RECALLED BY
Manufacturer, by telephone on May 22, 1999, and by press release on May 25, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Missouri, New York, California, Georgia, South Carolina, Colorado, Utah, 
Maryland, Pennsylvania, Illinois, Arizona, Tennessee.
QUANTITY
135 pounds were distributed.
REASON
Product was contaminated with Listeria monocytogenes.


________
PRODUCT
Peony Mark brand Dried Potato, in 6 ounce flexible plastic bags.  Product of 
China.  Recall #F-486-9.
CODE
None.
MANUFACTURER
Sun Wing Hong Food Ltd., Chai Wan, Hong Kong, China.
RECALLED BY
Tai Wing Hong Importer, Inc., Brooklyn, New York, by letter and by telephone on 
December 10, 1998, and by press release on December 7, 1998.  Completed recall 
resulted from sample analysis and follow-up by the New York State Department of 
Agriculture and Markets.
DISTRIBUTION
New York.
QUANTITY
21 cartons (100 packages per carton) were distributed.
REASON
Product contained undeclared sulfites.


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
________
PRODUCT
Lucky Lotus brand Hot Luu Tapioca Snack packaged in 7 ounce flexible plastic 
packages.  Product of Vietnam.
Recall #F-473-9.
CODE
None.
MANUFACTURER
Nam Hai Company, Ltd., Ho Chi Minh, Vietnam.
RECALLED BY
Kien Import Corporation, Brooklyn, New York, by letter on December 23, 1998.  
Completed recall resulted from sample analysis and follow-up by the New York 
State Department of Agriculture and Markets.
DISTRIBUTION
Massachusetts, Rhode Island, Connecticut, New Jersey, New York, Pennsylvania, 
Maryland, Virginia, North Carolina.
QUANTITY
31 cases (50 packages per case) were imported.
REASON
Product contained Ponceau 4R (an unapproved color additive) and it contained 
undeclared FD&C Yellow No. 5 and FD&C Blue No. 1.




RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
________
PRODUCT
Medical foods in steel cans with a paper label. Note that firm's "AMTF Tube 
Feeding" product in aluminum cans with a lithograph label are not a part of this 
recall:
a) AMTF Basic Formula, Ready to Use, 8 FL OZ. "Manufactured for Nyer Nutritional 
Systems, Inc. Phoenix, Arizona 85014".
b) Nutriflavor, Delicious Lemon Artificial Flavor, 8 FL OZ. "Manufactured for 
Nyer Nutritional Systems, Inc. Phoenix, Arizona 85014".
c) Nutriflavor, Delicious Orange Artificial Flavor, 8 FL OZ.  "Manufactured for 
Nyer Nutritional Systems, Inc. Phoenix, Arizona 85014".
d) AMTF Pediatric Formula, Ready to Use, 8 FL. OZ. "Manufactured for Nyer 
Nutritional Systems, Inc. Phoenix, Arizona 85014".
e) AMTF High-Protein Formula, Ready to Use, 8 FL. OZ. "Manufactured for Nyer 
Nutritional Systems, Inc. Phoenix, Arizona 85014".
f) AMTF Pulmonary Formula, Ready to Use, 8 FL. OZ. "Manufactured for  Nyer 
Nutritional Systems, Inc. Phoenix, Arizona 85014".
g) AMTF Diabetic Formula, Ready to Use, 8 FL OZ, "Manufactured for Nyer 
Nutritional Systems, Inc. Phoenix, Arizona 85014".
h) AMTF Trauma Formula, Ready to Use, 8 FL. OZ. "Manufactured for Nyer 
Nutritional Systems, Inc. Phoenix, Arizona 85014".
i) AMTF High-Cal 2.0 Formula, Ready to Use, 8 FL OZ, "Manufactured for Nyer 
Nutritional Systems, Inc. Phoenix, Arizona 85014".
j) AMTF Renal Formula, Ready to Use, 8 FL. OZ. "Manufactured for Nyer 
Nutritional Systems, Inc. Phoenix, Arizona 85014" 
Recall #F-475/484-9.
CODE
Codes beginning with: a) 9350; b) 9351; c) 9352; d) 9353; e) 9354; f) 9355; g) 
9356; h) 9357; i) 9358; j) 9359.
MANUFACTURER
Amboy of Michigan, LLC (formerly Curtice Burns Foods, Benton Harbor, Michigan.
RECALLED BY
Nyer Nutritional Systems, Phoenix, Arizona, by letter and telephone on January 
12, 1999, followed by visit.  Firm-initiated recall ongoing.
DISTRIBUTION
Tennessee, California, Arizona, Texas, Ohio, Oklahoma, South Carolina.
QUANTITY
24,246 cases (24 cans per case) are subject to recall.
REASON
Product is held in detinning cans.


RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II
________
PRODUCT
Compressed Medical Oxygen, USP, Rx product stored in D, N, and M6 size metal 
type cylinders.  Recall #D-272-9.
CODE
Lot numbers:  990-220-01, 990-221-01, 990-222-01.
MANUFACTURER
Homecare Concepts, Inc., Farmingdale, New York.
RECALLED BY
Manufacturer, on May 13, 1999.  Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
65 cylinders were distributed.
REASON
Incomplete testing for strength and identity.

________
PRODUCT
Cephradine Capsules USP, 250 mg in bottles of 100, Rx indicated in the treatment 
of respiratory tract infection, otitis media, skin and skin-structure 
infections, and urinary tract infections.  NDC #0093-3153-01.
Recall #D-274-9.
CODE
Lot #56214 EXP 9/99.
MANUFACTURER
Teva Pharmaceuticals, USA, Inc., Sellersville, Pennsylvania.
RECALLED BY
Manufacturer, by letter on June 15, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Approximately 10,852 bottles were distributed; firm estimated that 2,700 bottles 
remained on market at time of recall initiation.
REASON
Subpotency (stability).


RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
________
PRODUCT
Rx controlled-substance cough syrups:
a) ENDOTUSS HD(tm) Syrup, (Hydrocodone Bitartrate 1.67 mg, Phenylephrine 
Hydrochloride 5 mg, Chlorpheniramine Maleate 2 mg), in one pint (473 mL) bottles
b) POLYTINE D(tm) Syrup, (Phenylpropanolamine Hydrochloride 12.5 mg, 
Phenyltoloxamine Citrate 4 mg, Pyrilamine Maleate 4 mg, Pheniramine Maleate 4 
mg, Alcohol 4%), in one pint (473mL) bottles 
c) POLYTINE CS (tm) Syrup, (Codeine Phosphate 10 mg, Phenylpropanolamine 
Hydrochloride 12.5 mg, Brompheniramine Maleate 2 mg), in one pint (473 mL) 
bottles
d) CO-TUSSIN(tm) Syrup, (Hydrocodone Bitartrate 5 mg, Guaifenesin 100 mg) in one 
pint  (473 mL ) bottles, all lot numbers.  Recall #D-269/271-9 and D-273-9.
CODE
(a) NDC 58634-0004-1 (EndoTuss HD)
Lot Numbers/Exp. Dates:
AA146, 09/2000
AA152, 09/2000
AA159, 11/2000
AA164R, 12/2000
AA170, 2/2001
AA173, 3/2001
b) NDC 58634-0010-1 (Polytine D)
Lot Numbers/Exp. Date:
AA153, 9/2000
AA156, 10/2000
AA163, 11/2000
AA169, 3/2001
c) NDC 58634-0009-1 (Polytine CS)
Lot Numbers/Exp. Date:
AA154, 10/2000
AA160, 11/2000
AA166, 1/2001
AA177, 3/2001
d) NDC 58634-0032-1 (CoTussin)
Lot Numbers/Exp.Date:  
AA161, 11/2000
AA162, 12/2000
AA165, 12/2000
AA168, 2/2001
AA172, 3/2001
AA174, 3/2001.
MANUFACTURER
Signature Pharmaceuticals, Inc., Gloversville, New York.
RECALLED BY
Manufacturer, by letter dated June 8, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a) EndoTuss HD:  16,165/one pint (473 ml) bottles
b) Polytine D:   9,103/one pint (473 ml) bottles
c) Polytine CS:  5,293/one pint (473 ml) bottles  
d) CoTussin:     13,410/one pint (473 ml) bottles were distributed.
REASON
Lack of data to support labeled expiration date.

________
PRODUCT
Supac Analgesic Tablets (Acetaminophen 160 mg, Aspirin 230 mg, Caffeine 33 mg), 
in 100 and 1,000 tablet bottles, OTC analgesic. NDC Numbers:  0178 0100 01 and 
0178 0100 10.
Recall #D-275-9.
CODE
Lot Numbers         Expiration Date
6A12                January 1999
6G53                July 1999
7F14                June 2000
7K72                October 2000
8D63                October 1999.
MANUFACTURER
Mission Pharmacal Company (MPC), San Antonio, Texas.
RECALLED BY
Manufacturer, by letter dated April 6, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
7,703 100-tablet bottles and 784 1,000-tablet bottles were distributed.
REASON
Free Salicylic Acid values exceed USP limit and/or content uniformity failures 
for caffeine.

________
PRODUCT
Tilade Inhaler (Nedocromil Sodium Inhalation Aerosol) 1.75 mg per actuation, 8.5 
g (52 metered inhalations) professional samples, an inhaled anti-inflammatory 
agent for the preventive management of mild to moderate asthma in adult and 
pediatric patients 6 years of age and older. 
NDC 0585-0685-98.  Recall #D-276-9.
CODE
Lot #A70732 EXP 8/99.
MANUFACTURER
Fisons PLC Pharmaceutical Division, United Kingdom.
RECALLED BY
Rhone Poulenc Rorer, Collegeville, Pennsylvania, by telephone on April 27, 1999, 
followed by letter dated April 30, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Missouri and Arkansas.
QUANTITY
16 inhalers were distributed; firm estimates none remain on the market.
REASON
Failure to meet dose uniformity requirements.

_______
UPDATE
Miacalin Nasal Spray (Novartis Pharmaceuticals Corporation), Recall #D-254-9, 
which appeared in the June 23, 1999 Enforcement Report listed an incorrect lot 
number "324A6496".  The correct number is "324A6495".  Also, the recall covers 
all product "distributed" from 11/19/97 thru 5/20/99 rather than "manufactured" 
during that time.


RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
Red Blood Cells.  Recall #B-892-9.
CODE
Unit #FE00843.
MANUFACTURER
Healthcare Provider Services, Inc., Providence,
Rhode Island.
RECALLED BY
Manufacturer, by letter dated January 13, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Rhode Island.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who traveled to an area considered 
endemic for malaria.

________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-893/894-9.
CODE
Unit #L92144.
MANUFACTURER
Healthcare Provider Services, Inc., Providence, Rhode Island.
RECALLED BY
Manufacturer, by telephone on January 4, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Rhode Island.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who traveled to an area considered 
endemic for malaria.

________
PRODUCT
Red Blood Cells.  Recall #B-896-9.
CODE
Unit 04KF10531.
MANUFACTURER
American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by telephone on February 3, 1999, followed by letter dated 
February 10, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Massachusetts.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor with no hemoglobin results documented 
during screening.

________
PRODUCT
Red Blood Cells, Leukocytes Reduced.  Recall #B-898-9.
CODE
Unit #32GE13783.
MANUFACTURER
American Red Cross Blood Services, Madison, Wisconsin.
RECALLED BY
Manufacturer, by telephone and by letter on March 20, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit was distributed.
REASON
Blood product for which documentation of irradiation was incomplete.

________
PRODUCT
Platelets.  Recall #B-899-9.
CODE
Unit #32KM10592.
MANUFACTURER
American Red Cross Blood Services, Madison, Wisconsin.
RECALLED BY
Manufacturer, by telphone on August 10, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had traveled to an area designated 
as endemic for malaria.


________
PRODUCT>
a) Red Blood Cells; b) Platelets.  Recall #B-918/919-9.
CODE
Unit #03GM48049.
MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY
Manufacturer, by telephone on February 27, 1999, and March 11, 1999.  Firm-
initiated recall complete.
DISTRIBUTION
Georgia and Pennsylvania.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products may have been contaminated during collection of sample tubes.

________
PRODUCT
Platelets, Pheresis.  Recall #B-922-9.
CODE
Unit #6239753.
MANUFACTURER
Long Island Blood Services, Melville, New York.
RECALLED BY
Manufacturer, by letter dated May 23, 1999.  Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood product had an unacceptable platelet yield.

________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-923/924-9.
CODE
Unit numbers: a) 36LK10888, 36GK00286, and 36LC10683 
b) 36LK10888.
MANUFACTURER
American Red Cross Blood Services, Columbia, South Carolina.
RECALLED BY
Manufacturer, by letter dated November 16, 1998, or by telephone.  Firm-
initiated recall complete.
DISTRIBUTION
South Carolina, North Carolina, Georgia.
QUANTITY
a) 3 units; b) 1 unit was distributed.
REASON
Blood products were collected from a donor taking the drug, Methotrexate.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
________
PRODUCT
Synthes Sterile Drill Bits, Part #356.982.  Recall #Z-985-9.
CODE
Lot numbers:  A6G7403 and A6G6911.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter sent on April 1, 1998.  Firm-
initiated recall complete.
DISTRIBUTION
Nationwide, Canada, Switzerland.
QUANTITY
283 units were distributed.
REASON
Package insert was not placed in packaging when the product was sent out.

________
PRODUCT
Synthes Mandibular Modular Fixation System, Part #449.236.
Recall #Z-986-9.
CODE
Lot #1005.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter sent on March 25, 1998.  Firm-
initiated recall complete.
DISTRIBUTION
California, Pennsylvania, North Carolina, New York, Tennessee, Texas.
QUANTITY
21 units were distributed.
REASON
Package insert was not placed in packaging when the product was sent out.

________
PRODUCT
Synthes Spine Anterior Thoracolumbar Rod Clamp.
Recall #Z-987-9.
CODE
Part #498.160.
MANUFACTURER
Synthes (USA), West Chester, Pennsylvania.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter on August 25, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
California, Colorado, Florida, Georgia, Illinois, Massachusetts, Maryland, 
Minnesota, North Carolina, New Hampshire, New Jersey, New York, Pennsylvania, 
Texas, Utah, Virginia, Washington state.
QUANTITY
46 units were distributed.
REASON
The connector is not compatible with VentroFix System.  The distance at which 
the parallel connector maintains the rods is less than that which clamps 
provide.

________
PRODUCT
SK (sterile kits) kits, consisting of replacement seals and valves for cannulas:  
Model SK1, SK2, SK3, SK4.
Recall #Z-990/993-9.
CODE
Lots with Gibbons label:
981380   981691   981731   981781   983510   983511.
Lots with Smith & Nephew label:
981390   981671   981681   981700   982380   982780
982790   983450   983520.
MANUFACTURER
Gibbons Surgical Corporation, Virginia Beach, Virginia.
RECALLED BY
Manufacturer, by fax on May 17, 1999, followed by telephone.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Alabama, California, Pennsylvania, Texas, Michigan, Massachusetts, Missouri, 
Austria, Germany.
QUANTITY
17,439 kits were distributed.
REASON
Devices were dosed at a different level than that documented in validation 
study.

________
PRODUCT
Liftmaster Patient Hoist, Models 160 and 190 (Catalog numbers AA8940/AA8945).  
Recall #Z-1003/1004-9.
CODE
All units in the United States.
MANUFACTURER
Smith & Nephew Homecraft, Ltd., Farnham, Surrey, UK.
RECALLED BY
Smith & Nephew, Inc., Germantown, Wisconsin, by letter sent on June 7, 1999.  
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
24 lifts.
REASON
A bolt attaching the load-spreader to the boom of the lift can fracture due to 
metal fatigue over time and allow the patient to fall to the floor.

________
PRODUCT
Bard Cardiopulmonary Extracorporeal Cannulae, intended for use in cardiovascular 
surgery to cannulate vessels or perfuse arteries:
Z-1012-9 -- Models: 007300, 007301, 007302,007303.
Overall Length: 17.5cm, 14-20F, 3/8 inch connector.
Z-1013-9 -- Models: 007350,007351.
Overall Length: 17.5cm, 10&12F, 1/4 inch connector.
Z-1014-9  - Models: 007267, 007268, 007269, 007270, 007271.
Overall Length: 41.5cm,16-24F, 3/8 inch connector.
Z-1015-9 - Models: 007274, 007275, 007276, 007277, 007278, 007279, 007280, 
007281,007282.  Overall Length: 41.5cm,10-26F, 1/4 inch Connector
Z-1016-9 - Model: 007773.  Overall Length:27.5cm,12F, 1/4 inch connector.
Z-1017-9- Model: 007720, 007721, 007722, 007723.
Overall Length: 27.5cm,10-16F, 1/4 inch connector.
Z-1018-9 - Model: GA***** Special Order product attributes, such as length, 
French size, etc. GA*****
Item #'s: 007274-007282, 007773, 007720-007723
Special order-GAXXXXXX  
* (X =ANY NUMBER 0-9)
CODE
Lot numbers:  All Lot Numbers 43CI--- through 43LI---,
43AJ--- through 43EJ--- and Lot Numbers 43BI2019, 43BI2023 and 43BI2025.  Lot 
Numbers 43BI--- through 43LI---, 43AJ---through 43EJ---.  (- represents any 
number 0-9).
MANUFACTURER
C.R. Bard Puerto Rico, Las Piedras, Puerto Rico.
RECALLED BY
C.R. Bard, Inc., Haverhill, Massachusetts, by letter on June 7, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
46,539 units were distributed.
REASON
Sterile barrier may be compromised.

________
PRODUCT
Argyle DeLee Suction Catheter w/Mucous Trap, intended to aspirate liquids or 
semisolids from a patient's upper airway.  Recall #Z-1019-9.
CODE
Product code: 8888-257360.  Lot #9088054.
MANUFACTURER
Kelsar, S.A., Tijuana, Mexico.
RECALLED BY
Kendall Healthcare Products Company, Mansfield, Massachusetts, by fax on May 28, 
1999, followed by letter on June 1, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
85 cases (50 units per case) were distributed.
REASON
Product may be non-sterile.

________
PRODUCT
Laser Systems and Communication Lasers:
a) Model No. DY Laser Systems;
b) Model No. DYH Laser Systems;
c) Model No. LCT Class IIIb Communication Laser.
Recall #Z-1022/1024-9.
CODE
Model Number:  DY and DYH Laser Systems and LCT Communication Laser Systems.
MANUFACTURER
Power Technology, Inc., Mabelvale, Arkansas
RECALLED BY
Manufacturer.  FDA approved the firm's corrective action plan on June 15, 1999.  
Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
23 units were distributed.
REASON
The model DY and DYH laser systems were introduced into commerce uncertified and 
did not comply with the performance standard  (Section 538 of the Federal Food, 
Drug, and Cosmetic Act and 21 CFR 1010.2). The Class IIIb LCT communication 
lasers failed to have a remote interlock connector, an adequate beam attenuator, 
and the correct text on the warning logotype label (CFR 21 1040.10(f)(3), 21 CFR 
1040.10(f)(6), (21 CFR 1040.10(g)(2)(iii).

________
PRODUCT
Vitros ECi Immunodiagnostic System, a random access immunodiagnostic analyzer 
for use in clinical laboratories.  Recall #Z-1025-9.
CODE
Catalog No. 8633893, All units with the MOD E2 upgrade including but not limited 
to Serial Nos. 30000256, 30000311, 30000333, 30000351, 30000358, 30000364, 
30000369, 30000372, 30000376, 30000377, 30000386, 30000397, 30000402, 30000449, 
30000451, 30000478, 30000578, 30000602, 30000622, 30000660, 30000671, 30000678, 
30000697, 30000714, 30000736, 30000750, 30000752, 30000789, and 30000820.
MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, New York.
RECALLED BY
Manufacturer, by letters dated March 22 and 29, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 105 units are affected.
REASON
The shear valves in the reagent monitoring system may seize and stop dispensing 
reagent.

________
PRODUCT
MHS Manual Hexdriver, Part #10150, used to screw in or out the appropriate 
10010-XX size bone screws that secure the Alphatec modular barrel plate 
extensions against the proximal femur.  Recall #Z-1026-9.
CODE
Lot #M990188E.
MANUFACTURER
Alphatec Manufacturing Inc., Palm Desert, California.
RECALLED BY
Manufacturer, by letter on May 21, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Michigan, Georgia, Florida.
QUANTITY
27 units.
REASON
The hexdriver shaft was not heat treated as indicated in the specifications.

________
PRODUCT
IVAC MedSystem III Infusion System, a three-channel microprocessor based fluid 
delivery device for use to control and monitor infusion via intravenous, intra-
arterial or subcutaneous routes:  a) Model 2860: three-channel, general purpose, 
infusion pump, 110V;
b) Model 2863: three-channel, general purpose, infusion pump, 110V;
c) Model 2866: three-channel, general purpose, infusion pump, 220V 
(international), and a power supply board kit for use as a replacement power 
supply board for the Medsystem III pump.  Recall #Z-1027-9.
CODE 
Pump Serial Numbers less than 3351884; 
Kit Serial Numbers:  2860646 and 2860531.
MANUFACTURER
Alaris Medical Systems, Inc., San Diego, California.
RECALLED BY
Manufacturer, by letter on May 28, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Canada, The Netherlands, Japan, American Somoa.
QUANTITY
2,851 pumps and 466 power supply board kits were distributed.
REASON
Capacitors in the power supply board are failing causing the pumps to shut 
down/stop infusing without an alarm notifying the user.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
1.5 mm TI Cortex Screw Self Tapping 8 mm and 12 mm,
Part numbers 400.808.96 and 400.812.96.  
Recall #Z-988/989-9.
CODE
Part number 400.808.96 Lot number A3KT631 and Part number 400.812.96 Lot number 
A3KU527.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter on April 8, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
496 units were distributed.
REASON
Product was mislabeled.  The label placed on the device was blue instead of 
mauve.  A blue label is for 2.0 mm diameter screws.  The text on the label was 
correct.

________
PRODUCT
Ortho Chlamydia Antigen ELISA Test, diagnostic test kits.
Recall #Z-999-9.
CODE
Catalog #550080, Lot #550080.034, Expiration Dates: 8/23/99 
(reagent), 8/3/99 (kits).
MANUFACTURER
Meridian Diagnostics, Inc., Cincinnati, Ohio.
RECALLED BY
Meridian Diagnostics, Inc., Cincinnati, Ohio, by telephone, fax or mail on 
October 6, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
310 kits were distributed.
REASON
OPD Substrate Tablets have deteriorated resulting in inaccurate test results.

________
PRODUCT
ORTHO HSV Antigen ELISA Test, Modification, diagnostic test kits for the 
detection of herpes simplex virus.
Recall #Z-1000-9.
CODE
Catalog #550010, Lot #550010.042, EXP Date: 8/23/99 
(reagent), 1/19/99 (kit).
MANUFACTURER
Meridian Diagnostics, Inc., Cincinnati, Ohio.
RECALLED BY
Manufacturer, by telephone, fax or mail on October 6, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Nationwide and Italy.
QUANTITY
433 kits were distributed.
REASON
The OPD Substrate Tablets have deteriorated resulting in inaccurate test 
results.

________
PRODUCT
Synthes (USA) Midfacial System Part Numbers 446.516 and 447.515.  Recall #Z-
1005/1006-9.
CODE
Part number 446.516 Lot A3LU954 and Part number 447.515 lot A3LZ375.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter sent on July 22, 1998.  Firm-
initiated recall complete.
DISTRIBUTION
California, Florida, Michigan, Oregon, Texas.
QUANTITY
27 units were distributed.
REASON
Product was mislabeled.  The plates were anodized gold and should have been 
green/gray.

________
PRODUCT
One Shots HDL Precipitating Reagent, for in-vitro diagnostic use in 0.5 ml 
tubes, packaged in a blue plastic pail containing 250 tubes.  Recall #Z-1011-9.
CODE
Catalog No. 3335-250, Lot Nos. MI20, EXP 10/31/98, and NG07, EXP 8/31/99.
MANUFACTURER
Data Medical Associates, Inc., Arlington, Texas.
RECALLED BY
Manufacturer, by telephone on October 2, 1997.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
2,241 pails were distributed.
REASON
The reagent tubes contain less reagent volume than indicated on the label.

________
PRODUCT
Acufex Tibial Anchor Screw & Spiked Washer, indicated for use in fixation of 
soft tissue in orthopedic procedures.
Recall #Z-1020-9.
CODE
Catalog #7207-186.
MANUFACTURER
Smith & Nephew, Inc., Mansfield, Massachusetts.
RECALLED BY
Manufacturer, by letter on May 17, 1999, followed telephone and E-mail.  Firm-
initiated recall ongoing.
DISTRIBUTION
Arkansas, Colorado, Massachusetts, Pennsylvania, Texas, Wisconsin, Africa, 
Belgium, Singapore, France, Denmark.
QUANTITY
182 units were distributed.
REASON
The head of the screw may break during insertion.

________
PRODUCT
IMx Estradiol Reagent Pack, List #2215-22, 100 tests,an in-vitro diagnostic 
microparticle enzyme immunoassay for the quantitative measurement of estradiol 
in human serumand plasma on the IMx Analyzer.  Recall #Z-1021-9.
CODE
Lot Numbers:  49001M100, 51758M300, 51585M400.
MANUFACTURER
Abbott Laboratories, Abbott Park, Illinois.
RECALLED BY
Manufacturer, by letter dated June 11, 1999, followed by telephone.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
3,037 packs were distributed.
REASON
Lots may show underrecovery of estradiol with undiluted patient specimens.


END OF ENFORCEMENT REPORT FOR JUNE 30, 1999.