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.
June 25, 1997 97-26
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I =============
_______________
PRODUCT Western Family Maple Nut Ice Cream, in «
gallon cardboard containers. Recall #F-412-7.
CODE 06-1187 followed by four random numbers, then
Code 7042 printed on an end flap.
MANUFACTURER Humboldt Creamery, Fortuna, California.
RECALLED BY Manufacturer, by fax and E-mail on April 2,
1997, followed by press release issued through
California Department of Food and Agriculture
on April 7, 1997. Press was issued by the
state of Washington on April 8, 1997 and in
Oregon on April 8, 1997. Firm-initiated
recall complete.
DISTRIBUTION Oregon, Washington state, California.
QUANTITY 1,800 containers were distributed.
REASON Product contains undeclared peanuts, cashews,
pecans, and almonds.
_______________
PRODUCT a) Chocolate Snickers Layer Cake, net weight
23 ounces; b) Carrot Cake approximately 1-1.5
pounds. Recall #F-466/467-7.
CODE All product with undeclared nuts.
MANUFACTURER Supermarkets General Corporation, Woodbridge,
New Jersey.
RECALLED BY Manufacturer, by E-Mail message on January 27,
1997. Completed recall resulted from sample
analysis and followup by the New York State
Department of Agriculture and Markets.
DISTRIBUTION Delaware, New Jersey, New York, Pennsylvania.
QUANTITY Undetermined.
REASON a) Product contains undeclared peanuts; b)
Product contains undeclared walnuts.
_______________
PRODUCT SuperPretzel Softstix Cheese Filled Soft
Pretzel Sticks, Cheddar Flavor.
Recall #F-468-7.
CODE 092197B (retail box), 092196B (case).
MANUFACTURER J & J Snack Foods Corporation, Pennsauken, New
Jersey.
RECALLED BY Manufacturer, by public notice on November 13,
1996, press release, and by telephone November
13-14, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 13,380 retail units were distributed; firm
estimated that 6,000 retail boxes remained on
market at time of recall initiation.
REASON Product contains undeclared peanut butter.
Some boxes contain peanut butter and jelly
filled product along with or in lieu of cheese
filled product.
_______________
PRODUCT Good 'N Quick Extended Shelf Life Liquid Whole
Eggs. Recall #F-469-7.
CODE 077-7 Use By April 12, 97.
MANUFACTURER Wilcox Family Farms, Roy, Washington.
RECALLED BY Manufacturer, by telephone on April 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION Washington state and Oregon.
QUANTITY 27,867 pounds were distributed.
REASON Product may be contaminated with Listeria
monocytogenes.
_______________
PRODUCT Chocolate Chip Cookie Dough Ice Cream; a) in «
gallon packages; b) in 3 gallon bulk
containers. Recall F-476/477-7.
CODE a) All date codes prior to 18196; b) All date
codes prior to 20796.
MANUFACTURER Welsh Farms, Inc., West Caldwell, New Jersey.
RECALLED BY Welsh Farms, Inc., Long Valley, New Jersey, by
press release on August 9, 1996, followed by
letter dated August 13, 1996. Firm-initiated
field correction complete.
DISTRIBUTION New York, New Jersey, Pennsylvania.
QUANTITY 40,520 units were distributed.
-2-REASON a) Product contains undeclared eggs; b)
Product does not bear an ingredient statement
and contains undeclared eggs and wheat flour.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============
_______________
PRODUCT Deco-Pac edible decorations:
1. The Lion King, box of 90 decorations
product 9802, net wt. 4.87 ozs.
2. Pocahontas, box of 90 decorations product
9803, net. wt. 6.35 ozs.
3. Winnie the Pooh, box of 90 decorations
product 9804, net wt. 6.35 ozs.
4. Esmeralda & Quasimodo, box of 90
decorations product 9805, net wt. 4.87 ozs.
5. 101 Dalmatians, box of 90 decorations
product 9806, net. wt. 4.85
6. Mickey & Friends, box of 90 decorations
product 9807, net. wt. 4.85
7. Nickelodeon Rugrats, box of 90 decorations
product 9808, net wt. 4.87
8 Looney Tunes, box of 90 decorations product
9809, net wt. 4.87
9. Florida Panthers, box of 6 decorations
product 9810, net wt. 6.35 oz.s
10. New Jersey Devils, box of 6 decorations
product 9811, net wt. 6.35 ozs
11. New York Islanders, box of 6 decorations
product 9812, net wt. 6.35 ozs.
12. F-326-7 New York Rangers, box of 6
decorations product 9813, net wt. 6.35 ozs.
13. Philadelphia Flyers, box of 6 decorations
product 9814, net wt. 6.35 ozs.
14. Tampa Bay Lightening, box of 6
decorations product 9815, net wt. 6.35 ozs.
15. Washington Capitals, box of 6 decorations
product 9816, net wt. 6.35 ozs.
16. Boston Bruins, box of 6 decorations
product 9817, net wt. 7.55 ozs.
17. Buffalo Sabres, box of 6 decorations
product 9818, net wt. 7.55 ozs.
18. Hartford Whalers, box of 6 decorations
product 9819, net wt. 6.35 ozs.
19. Montreal Canadians, box of 6 decorations
product 9820, net wt. 6.35 ozs.
20. Oklahoma Senators, box of 6 decorations
product 9821, net wt. 6.35 ozs.
21. Pittsburgh Penguins, box of 6 decorations
product 9822, net wt 6.35 ozs,
22. Chicago Blackhawks, box of 6 decorations
product 9823, net wt. 7.55 ozs.
-3- 23. Dallas Stars, box of 6 decorations
product 9824, net wt. 6.35 ozs.
24. Detroit Red Wings, box of 6 decorations
product 9825, net wt. 7.55 ozs.
25. St. Louis Blues, box of 6 decorations
product 9826, net wt. 7.55 ozs.
26. Toronto Maple Leafs, box of 6 decorations
product 9827, net wt. 6.35 ozs.
27. Phoenix Coyotes, box of 6 decorations
product 9828, net wt. 7.55 ozs.
28. Mighty Ducks of Anaheim, box of 6
decorations product 9829, net wt. 6.35 ozs.
29. Calgary Flames, box of 6 decorations
product 9830, net wt. 6.35 ozs.
30. Colorado Avalanche, box of 6 decorations
product 9831, net wt. 7.55 ozs.
31. Edmonton Oilers, box of 6 decorations
product 9832, net wt. 6.35 ozs.
32. Los Angeles Kin, box of 6 decorations
product 9833, net wt. 7.55 ozs.
33. San Hose Sharks, box of 6 decorations
product 9834, net wt. 7.55 ozs.
34. Vancouver Canucks, box of 6 decorations
product 9835, net wt. 6.35 ozs.
35. Esmeralda & Djali, box of 6 decorations
product 9846, net wt. 3.81 ozs.
36. Minnie Mouse Party, box of 6 decorations
product 9866, net wt. 5.64 ozs.
37. Mickey Mouse Party, box of 6 decorations
product 9867, net wt 5.64 ozs.
Recall #F-315/351-7.
CODE All lots.
MANUFACTURER G.T. Culpitt & Sons, Ltd., England, UK.
RECALLED BY DecoPac, Inc., Minneapolis, Minnesota, by
letter dated February 18, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 11,052 boxes were distributed; firm estimated
that 1,100 boxes remained on market at time of
recall initiation.
REASON Product is misbranded due to undeclared FD&C
Yellow No. 5 and FD&C Red #3.
_______________
PRODUCT Rice-A-Roni Pasta Roni Angel Hair Pasta with
Lemon & Butter Sauce, in 4.7 ounce boxes.
Recall #F-464-7.
CODE UPC #15300-44052; Best Before: NOV 18 97 B
24.
MANUFACTURER Golden Grain Company, Bridgeview, Illinois.
-4-RECALLED BY Quaker Oats Company, Chicago, Illinois, by
telephone on April 11, 1997, followed by
letter dated April 16, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY Approximately 90 cases (12 boxes per case)
were distributed.
REASON Product contains undeclared soy protein, soy
flour and wheat-gluten.
_______________
PRODUCT Paskesz Assorted Sugarfree Candy, Kosher -
Parve, net weight 2.5 ounces, in flexible
plastic packages. Recall #F-465-7.
CODE None.
MANUFACTURER Estee Candy, Parsippany, New Jersey.
RECALLED BY Paskesz Candy Company, Inc., Brooklyn, New
York, by letter on September 19, 1996.
Completed recall resulted from sample analysis
and followup by the New York State Department
of Agriculture and Markets.
DISTRIBUTION New York, New Jersey, Pennsylvania.
QUANTITY 115 cases (24 packages per case) were
distributed.
REASON Lack of sorbitol warning statement; presence
of undeclared FD&C Yellow No.5, FD&C, Yellow
No.6, FD&C Red No.40 and FD&C Blue No.1; and
lack of nutrition labeling.
_______________
PRODUCT Frozen Fruit Bars and Cups:
a) FrutStix Fat Free Strawberry Frozen Fruit
Bar
b) Frubet Fat Free Strawberry Fruit Cup
c) FrutStix Fat Free Fruit Blend Frozen Fruit
Bar
FrutStix Creamy Strawberry Fresh Fruit Frozen
on a Stick. Recall #F-471-474-7.
CODE For the Strawberry 6/24 - 4 oz. size is either
2.5 or 4 ounce: lot numbers: SFL20MZ,
SFL31MZ, SFL18MZ, SFL30MZ, SFB06NC, SFBO5NC,
SFC26NC, SFC17NC, SFC14NC, SFL13MZ, SFB10NC,
SFC25NC
For Creamy Strawberry 6/24 - 4 oz.: Lot
numbers: SFDO1NC, SFC20NC, SFD02NC
For Fruit Blend 12/4 - 2.5 oz.: Lot SFDO1NC
For Fruit Blend (Frubet) 12/4 - 3.5 oz: Lot
FBJ08MZ.
MANUFACTURER The Frutstix Company, Division of Lafayette
Foods, San Diego, California.
RECALLED BY Lafayette Foods, Santa Barbara, California, by
letter on or about April 2, 1997, and April
23, 1997. Firm-initiated recall ongoing.
-5-DISTRIBUTION Nationwide and Canada.
QUANTITY 3,547 cases were distributed; firm estimates
none remains on the market.
REASON The products were processed from strawberry
lots that were associated with a March 1997
illness outbreak of Hepatitis A in Michigan.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ===========
_______________
PRODUCT Food Lion Shredded Low-Moisture Part-Skim
Mozzarella Cheese, 32 ounces.
Recall #F-459-7.
CODE Sell by JUN 21 97N1 and JUN 21 97N2.
MANUFACTURER Great Lakes Cheese of Wisconsin, Inc.,
Plymouth, Wisconsin.
RECALLED BY Manufacturer, by letter on April 23, 1997.
Firm-initiated recall complete.
DISTRIBUTION Florida, North Carolina, Pennsylvania, South
Carolina, Tennessee,Virginia.
QUANTITY 2,130 cases (5 packages per case) were
distributed.
REASON Product may contain small pieces of metal or
wire.
_______________
PRODUCT Canned White Beans in Brine, under the
following brand names:
El Valle - private label for Quality Food
Products Corp.
Ricura - private label for Almacen Bedford
Ramirez
Food Club - private label for Pueblo
Supermarkets. Recall #F-470-7.
CODE QATFW AND QNJFW.
MANUFACTURER Quality Food Products, Yauco, Puerto Rico.
RECALLED BY Manufacturer, by visit on June 11, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY 632 cases (24 cans per case of lot QATFW; and
240 cases (24 cans per case) of lot QNJFW.
REASON Product was shipped without evaluation of
scheduled process deviations.
_______________
PRODUCT Mott's 100% Apple Juice from concentrate, in
64 fluid ounce plastic bottles.
Recall #F-475-7.
CODE Item 31648, Lot A60523.
MANUFACTURER Mott's, Inc., Aspers, Pennsylvania.
RECALLED BY Mott's, USA, Stamford, Connecticut, by letter
dated February 27, 1997. Firm-initiated
recall complete.
-6-DISTRIBUTION Michigan, Illinois.
QUANTITY 20,029 cases were distributed.
REASON Product is adulterated due to an off flavor.
RECALLS AND FIELD CORRECTIONS: DRUGS: CLASS
II ==============
_______________
PRODUCT Various Rx drugs:
a) Benadryl (Diphenhydramine Hydrochloride
Injection USP), 50 mg/ml, in 10 ml vials
b) Dilantin (Phenytoin Sodium Injection, USP),
250 mg, in 5 ml (ready/mixed) vials
c) Ketalar (Ketamine Hydrochloride Injection,
USP), 50 mg/ml, in 10 ml vials
d) Ketalar (Ketamine Hydrochloride Injection,
USP), 100 mg/ml, in 5 ml vials
e) Cerebyx (Fosphenytoin Sodium) Injection, 50
mg PE/ml, in 10 ml vials.
Recall #D-191/195-7.
CODE Lot numbers: a) 031N6P; b) 025N6P; c) 002N6P;
d) 032N6P; e) 01706P.
MANUFACTURER Warner-Lambert Company, Parke-Davis Sterile
Products Division, Rochester, Michigan.
RECALLED BY The Parke-Davis Division of Warner-Lambert
Company, Morris Plains, New Jersey, by letter
on May 8, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION a-d) Nationwide and international; e) Georgia,
Massachusetts, Ohio, Pennsylvania.
QUANTITY a) 2,897 units; b) 3,330 units; c) 1,468 units
d) 2,862 units; e) 12 units were distributed.
REASON Lack of assurance of sterility.
_______________
PRODUCT SoloPak Metoclopramide Injection USP, 10 mg
(5 mg/ml), in 2ml vials, Rx intravenous or
intramuscular injection for the relief of
symptoms associated with acute and recurrent
diabetic gastric stasis, and for the
prophylaxis of postoperative nausea nd
vomiting in those circumstances where
nasogastric suction is undesirable.
Recall #D-197-7.
CODE Lot #960456 EXP 4/98.
MANUFACTURER Solopak Laboratories, Inc., Elk Grove Village,
Illinois.
RECALLED BY Manufacturer, by letter dated June 3, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 138,050 vials were distributed; firm estimated
that 1% of product remained on market at time
of recall initiation.
-7-REASON Product exceeds in-process bulk bioburden
specification.
_______________
PRODUCT SoloPak Heparin Lock Flush Solution, USP,
Preservative Free, 10 USP units/ml packaged in
3 ml pre-filled syringes for maintenance of
patency of indwelling intravenous catheters
designed for intermittent injection therapy or
blood sampling and not to be used for
anticoagulant therapy:
Catalog #10673: 3 ml Hy-Pod Syringe with 25G x
5/8" needle, individually wrapped, 120 per
carton; Catalog #10683: 3 ml Hy-Pod Syringe,
needleless individually wrapped, 120 per
carton; Catalog #11773: 3 ml Hy-Pod Syringe,
contained in the Lok-Pak-N Heparin Lock Flush
Procedure Pack, 200 per case; Catalog #06003:
3 ml Hy-Pod Syringe, contained in the Lok-Pak
Heparin Lock Flush Procedure Pack, needle not
included, 200 per case. Recall #D-199-7.
CODE Syringe lot 95L008, packaged as:
Catalog #11773: lot 95L008B
Catalog #06003: lot 95L008C
Catalog #10673: lot 95L008D
Catalog #10683: lot 95L008E.
MANUFACTURER SoloPak Medical Products Inc., Franklin Park,
Illinois.
RECALLED BY SoloPak Medical Products Inc., Elk Grove
Village, Illinois, by letter dated May 13,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 62,212 syringes were distributed; firm
estimated that 9% of the product remained on
market at time of recall initiation.
REASON Subpotent (stability).
_______________
PRODUCT Dilantin Infatabs (Phenytoin Tablets, USP) 50
mg, in bottles of 100 and in blister pack of
10 x 10, used in the treatment of seizures.
Recall #D-209-7.
CODE Lot numbers: 07006V 10/98 (bottles of 100,
07106V 10/98 (bottles of 100), 07106VA 10/98
(blister pack of 10x10).
MANUFACTURER Warner Lambert Company, Vega Baja, Puerto
Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert,
Morris Plains, New Jersey, by letter on May 9,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 39,647 units were distributed.
-8-REASON Product failed dissolution testing
(stability).
_______________
PRODUCT Solopak Gentamicin Sulfate Injection, USP, 80
mg/2mL (40 mg/mL), in 2 mL multiple dose
vials, Rx antibiotic. Recall #D-210-7.
CODE Lot #951218 EXP 06/97.
MANUFACTURER SoloPak Laboratories, Inc., Elk Grove Village,
Illinois.
RECALLED BY Manufacturer, by letter dated May 14, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 193,850 vials were distributed.
REASON Super-potency.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ===========
_______________
PRODUCT Fiorinal Tablets; and Fiortal Tablets (Aspirin
325 mg/Caffeine 40 mg/Butalbital 50 mg), in
100 and 1000 unit bottles, Rx indicated for
the relief of the symptom complex of tension
headache. Recall #D-196-7.
CODE Sandoz Label
Fiorinal Tablets, Bottles of 1000s:
Lot # 845Y0194 Expiration 4/98
Lot # 861Y0550 Expiration 9/98
Fiorinal Tablets, Bottles of 100s:
Lot # 846Y0193 Expiration 4/98
Lot # 847Y0193 Expiration 4/98
Lot # 848Y0193 Expiration 4/98
Lot # 850Y0427 Expiration 5/98
Creighton Label
Fiortal Tablets, Bottles of 1000s:
Lot # 010Y0088 Expiration 3/98
Lot # 011Y0088 Expiration 3/98
Lot # 012Y0345 Expiration 4/98
Fiortal Tablets, Bottles of 100s:
Lot # 013Y0507 Expiration 4/98.
MANUFACTURER Sandoz Pharmaceuticals Corporation and
Creighton Products Corporation, East Hanover,
New Jersey.
RECALLED BY Manufacturer, by fax on November 25, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Fiorinal Tabs 1000's:
Lot # Amount Shipped
846Y0194 728
861Y0550 498
-9- Fiorinal Tabs 100's:
846Y0193 7387
847Y0193 7306
848Y0193 7322
850Y0427 4044
Fiortal Tabs 1000's:
010Y0088 723
011Y0088 726
012Y0345 542
Fiortal Tabs 100's:
013Y0507 3847.
REASON Content uniformity failure.
_______________
PRODUCT SoloPak Magnesium Sulfate Injection USP, 50%,
in 2 ml vials, preservative free, Rx
parenteral anticonvulsant. Recall #D-198-7.
CODE Lot #951140 EXP 11/98.
MANUFACTURER SoloPak Laboratories, Inc., Elk Grove Village,
Illinois.
RECALLED BY Manufacturer, by letter dated May 12, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 175,550 vials were distributed; firm estimated
that 1% of product remained on market at time
of recall initiation.
REASON Product exceeds pH specifications in stability
testing.
_______________
PRODUCT SoloPak Heparin products, the lock flush
solution is used for maintenance of patency of
indwelling intravenous catheters designed for
intermittent injection therapy or blood
sampling, and not to be used for anticoagulant
therapy, while the heparin sodium injection is
used for anti-coagulant:
a) Heparin Lock Flush Solution, USP, 100 u/mL,
Preservative Free, 1 mL fill in 2 Ml single
dose vials and 2 and 5 mL single dose vials;
b) Heparin Lock Flush Solution, USP, 10 mL,
Preserved, 10 and 20 ml multiple dose vials
c) Heparin Lock Flush Solution, Preserved, 100
u/mL, 10 and 30 mL multiple dose vials
d) Heparin Sodium Injection, USP, Preserved,
porcine, 1000 u/mL, in 10 and 30 mL multiple
dose vials. Recall #D-200/203-7.
CODE All lots within expiration date.
MANUFACTURER SoloPak Laboratories, Inc., Elk Grove Village,
Illinois.
RECALLED BY Manufacturer, by letter dated May 14, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
-10-Quantity 12,984,850 vials were distributed; firm
estimated that 25% of the product remained on
market at time of recall initiation.
REASON Product contains visible particulate matter.
_______________
PRODUCT Thyrolar Tablets (Liotrix Tablets, USP), in
bottles of 100, used in the treatment of the
thyroid: a) 1/4 mg; b) « mg; c) 1 mg; d) 2 mg;
e) 3 mg. Recall #D-204/208-7.
CODE All lots received since September 1996 held
unrefrigerated.
MANUFACTURER Forest Pharmaceuticals, Inc., St. Louis,
Missouri.
RECALLED BY Giant of Maryland, Inc., Landover, Maryland,
by voice mail on May 8, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Maryland, Virginia, Pennsylvania, New Jersey,
Delaware.
QUANTITY a) 13 bottles; b) 7 bottles; c) 149 bottles;
d) 74 bottles; e) 23 bottles were distributed.
REASON Improper temperature storage.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT Red Blood Cells. Recall #B-411-7.
CODE Unit #39G81520.
MANUFACTURER American Red Cross, Huntington, West Virginia.
RECALLED BY Manufacturer, by telephone on November 22,
1996. Firm-initiated recall complete.
DISTRIBUTION West Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled as "Nonreactive for
CMV Antibody" but tested positive for CMV.
_______________
PRODUCT Whole Blood; b) Red Blood Cells; c)Platelets;
d) Recovered Plasma. Recall #B-916/919-7.
CODE Unit numbers: a) Unit 29H08103,
b) 29H99670, 29L52538, 29T11077, 29R33231,
29N00091, 29G99804, 29H08204, 29H08770,
29H09245, 29R39469, 29R39492, 29R39494,
29R39490, 29Y34894, 29Y34844, 29Y34910,
29FR31223, 29FR57772; c) 29FR57772
d) 29H99670, 29L52538, 29T11077, 29N00091,
29H08204, 29H09245, 29R39469, 29R39492,
29R39494, 29R39490, 29Y34894, 29Y34844,
29Y34910, 29FR31223, 29FR57772, 29H00789,
29H05072, 29H05934.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
-11-RECALLED BY Manufacturer, by letter dated March 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Virginia, North Carolina, California,
Pennsylvania, Switzerland.
QUANTITY a) 1 unit; b) 18 units; c) 1 unit; d) 18 units
were distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1), or the hepatitis B
surface antigen (HbsAg).
_______________
PRODUCT Platelets. Recall #B-924-7.
CODE Unit #18FQ02562.
MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
RECALLED BY Manufacturer, by letter dated June 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
whole blood that was shipped at an
unacceptable temperature.
_______________
PRODUCT Whole Blood. Recall #B-926-7.
CODE Unit #18Q15137.
MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
RECALLED BY Manufacturer, by letter dated November 15,
1996. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
had been previously deferred for a history of
hepatitis.
_______________
PRODUCT a) Platelets for further manufacture; b)
Recovered Plasma. Recall #B-927/928-7.
CODE Unit #18R82905.
MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
RECALLED BY Manufacturer, by letters dated April 9 and 10,
1997. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products may have been contaminated.
-12-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-920/921-7.
CODE Unit numbers 29M29822, 29N04875.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
RECALLED BY Manufacturer, by letter dated March 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Virginia, North Carolina, California,
Pennsylvania, Switzerland.
QUANTITY 2 units of each component were distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodefiency virus
type 1 (anti-HIV-1), or the hepatitis B
surface antigen (HbsAg).
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II ==========
_______________
PRODUCT ProView Self Sealing Sterilization Pouch, used
to contain items during sterilization.
Recall #Z-661-7.
CODE Product #PM5410, Lot #6312.
MANUFACTURER Cottrell, Ltd., Englewood, Colorado.
RECALLED BY Manufacturer, by telephone beginning on May
30, 1997, followed by letter. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, South Africa.
QUANTITY 316 cases (1,896 boxes) plus 6 individual
boxes were distributed.
REASON The specification for seal strength has not
been met which could result in the pouch
opening during use or storage thereby
compromising the sterility of the instrument
inside.
_______________
PRODUCT 3.5mm Cortex Screw, Part #204.850, an
orthopedic medical device used for bone
fixation. Recall #Z-663-7.
CODE Lot #A31B276.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania, by
memorandum on June 5, 1996. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
REASON The 3.5mm Cortex Screws were labeled as 4.5mm
cannulated screws.
-13-_______________
PRODUCT Chlamydia Stat Pak, a rapid, visual assay for
the detection of Chlamydia trachomatis antigen
in endocervical, urethral, or male urine
specimens. Recall #Z-666-7.
CODE Lot #CH031397 EXP 2/28/99.
MANUFACTURER Chembio Diagnostic Systems, Inc., Medford, New
York.
RECALLED BY Manufacturer, by telephone on April 30, 1997,
followed by letter on May 1, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Russia, Egypt, Jamaica.
QUANTITY 9,040 paks were distributed.
REASON The cassette has a shortened "lip" for holding
the test membrane in place, making it
difficult to read the results.
_______________
UPDATE Z-516-7. Passport Monitor with C02 Capability,
which appeared in the May 14, 1997 Enforcement
Report should read:
CODE: Model Numbers: 0998-00-0095-61, 62, 63,
64, 66, 68, 70, 71, 72, 73, 74, 75, 76, B61,
B62, B63, B64, H61, H62, H63, H64, H70, H71,
H72, N61, N62, N63, and N64;
Model Numbers: 0998-00-0126-61, 62, 63, 64,
73, 74, 75, 76, N61, N62, N63, and N64.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III =========
_______________
PRODUCT Balloon Stone Extractors:
a) Product Code BSE-21500
b) Product Code BSE-21505
c) Product Code BSE-21510
a) Product Code BSE-21500
b) Product Code BSE-21505
c) Product Code BSE-21510.
Recall #Z-658/660-7.
Code Lot numbers: a) 072695-05, 060695-03
b) 07095-09, 062695-04
c) 072695-10, 070695-02, 062695-05.
MANUFACTURER Wiltek Medical, Inc., Rural Hall, North
Carolina.
RECALLED BY Manufacturer, by fax on September 1 and 6,
1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 477 units were distributed.
REASON Products may fail to function as intended
during procedure due to defective adhesive.
-14-_______________
PRODUCT Bacto Leptospira Enrichment EMJH, Product No.
0795-73, for in-vitro cultivation of
Leptospira. Recall #Z-662-7.
CODE Lot Nos. 72207JA, 72208JA, 72209JA, 73283JA,
73289JA, 74265JA, 74370JA, 74754JA, 75099JA,
76485JA, 79680JA, 80758JA, 80828JA, 81666JA,
84380JB, 85611JA, 86735JA, 87323JA, 87579JA,
88532JA, 88533JA, 88534JA, 88535JA, 91980JA,
92150JA, 92152JA, 92153JA, 95796JA, 95843JA,
98857JA, 100638JB, and 100639JA.
MANUFACTURER Difco Laboratories, Detroit, Michigan.
RECALLED BY Difco Laboratories, Livonia, Michigan, by
letters dated April 26, 1997, and May 8, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,781 packages were distributed.
REASON The product is contaminated with Leptospira
sp.
_______________
PRODUCT Periosteal Elevators, used to lift soft tissue
so that the surgeon can get to the area of
interest:
a) 3mm Periosteal Elevator, Part No. 399.48
b) 6mm Periosteal Elevator, Part No. 399.40.
Recall #Z-664/665-7.
CODE Lot numbers: a) Lot A7FA02; b) A7FA02.
MANUFACTURER CHR. Diener GmbH Company, KG., Germany.
RECALLED BY Synthes (USA), Paoli, Pennsylvania, by visit
on August 13, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY (a) 75 units; (b) 35 units were distributed.
REASON Some 3mm elevators were etched as 6mm
elevators and visa versa.
-15-
END OF ENFORCEMENT REPORT FOR JUNE 25, 1997. BLANK PAGES MAY FOLLOW.
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