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.
November 26, 1997 97-48
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
UPDATE Recall #F-093/119-8, Hummus and Baba Ganouch, which
appeared in the November 19, 1997, Enforcement Report
is a Class I Recall.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Mead Johnson Magnacal Renal Ready to use for oral or
tube feedings, vanilla honey graham flavor in 8 fluid
ounce cans.
Recall #F-124-8.
CODE Lots AHO00 EXP. 5/97, AKO01 EXP. 7/97, ALO02 EXP 8/97, AMO03
EXP. 9/97, AMO003H EXP. 9/97, AMO04 EXP. 9/97, AAH05 EXP.
2/98, and ACH06 EXP. 4-98.
MANUFACTURER Mid-American Dairymen, Cabool, Missouri.
RECALLED BY Mead Johnson Nutritionals, Evansville, Indiana, by
mailgram sent on June 13, 1997. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 619,000 cans were distributed.
REASON The product was found contaminated with Bacillus and
Cellumonas bacteria. It is also unfit for food based
on thickening and gelling.
_______________
PRODUCT Celebrity brand Whole Strawberries in Light Syrup, in
15 ounce containers.
Recall #F-125-8.
CODE The product does not bear any codes, but the warehouse
assigns a lot number to each shipment upon receipt. The
July shipment was assigned "lot #46885".
MANUFACTURER Conservas y Frutas S.A., Murcia, Spain.
RECALLED BY Atlanta Corporation, Elizabeth, New Jersey, by
letter sent on October 7, 1997, followed by
telephone. Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, New York, Michigan, Rhode Island,
Massachusetts.
QUANTITY 727 cartons were distributed.
REASON The product contains the unapproved color additive
Ponceau 4R.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ===========
_______________
PRODUCT Sunny Delight California Style Citrus Punch
Beverage, in 64 fluid ounce plastic bottles.
Recall #F-120-8.
CODE The bottles are identified with the code
range: JAN19 H 11:21 through JAN19 H 12:21.
The cases are identified with the code range:
7265 H 11:21 JAN 19 through 7265 H 12:21
JAN 19.
MANUFACTURER Sundor Brands, Inc., Atlanta, Georgia.
RECALLED BY The Procter & Gamble Company, Cincinnati, Ohio, by
E-mail on October 21, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Florida, North Carolina, Georgia, Mississippi.
QUANTITY 19,200 bottles (2,400 cases) were distributed.
REASON Product is off-flavor due to excess salt.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ============
_______________
PRODUCT Zinc Sulfate Injection, 10 mg/ml, in 30 ml
vials. Recall #D-034-8.
CODE "Prep" dates 4/1/96 through 10/1/96.
MANUFACTURER Apothe'Cure, Inc., Dallas, Texas.
RECALLED BY Manufacturer, by letter on November 25, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
-2-
QUANTITY 6 vials were distributed.
REASON Superpotent.
_______________
PRODUCT Videx Tablets (Didanosine), Chewable/
Dispersible, 100 mg, unit dose, blister
strips packaged in units of 10 per
strip, used for the treatment of HIV
infection. (NDC #0087-6652-01).
Recall #D-035-8.
CODE Lot #MJH61 EXP 5/3/98.
MANUFACTURER Bristol Myers Squibb, Princeton, New Jersey.
RECALLED BY AmeriSource Corporation, Louisville, Kentucky,
by telephone on November 6, 1997. Firm-
initiated recall ongoing.
DISTRIBUTION Michigan.
QUANTITY 178 unit dose packets were distributed.
REASON Mislabeling - Some of the strips are labeled
as containing Guaifenesin LA Tablets, 600 mg,
Lot #S6159D02C.
_______________
PRODUCT Maxified-G Sustained Release Tablets, (Pseudoephedrine
HCl 60 mg/Guaifenesin 500 mg), distributed by
MCR/American Pharmaceutical, Inc., in 100 tablet
plastic bottles, Rx for the temporary relief of nasal
congestion and dry, non-productive cough associated
with the common cold and other respiratory allergies.
(NDC #58605-506-01). Recall #D-038-8.
CODE Lot #D970316B EXP 4/99.
MANUFACTURER Mikart, Inc., Atlanta, Georgia.
RECALLED BY Manufacturer, by letter dated July 25, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,500 bottles were distributed.
REASON Foreign tablet (Pyrazinamide).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ===========
_______________
PRODUCT Colrex Compound Capsules (Codeine Phosphate 16
mg/Acetaminophen 325 mg/Phenylephrine Hydrochloride 10
mg/Chlorpheniramine Maleate 2 mg), in 100 capsule
plastic bottles, Rx for the temporary relief of cough
congestion, headache and muscle soreness of common
colds and upper respiratory infections.
(NDC #55499-0840-1). Recall #D-036-8.
CODE 951429L EXP 11/97.
MANUFACTURER Mikart, Inc., Atlanta, Georgia.
-3-
RECALLED BY Manufacturer, by letter on July 2, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,632 bottles were distributed.
REASON Lot released prior to completed process validation
(potential blend uniformity failure -
Chlorpheniramine).
_______________
PRODUCT Protid Tablets (Acetaminophen 500 mg/Phenylephrine
Hydrochloride 40 mg/Chlorpheniramine Maleate 8 mg), in
100 caplet bottles and physician samples of 2's, Rx for
the relief of multiple symptoms of nasal and eustachian
tube congestion, sneezing, runny nose, watery eyes,
etc.
(NDC #10892-127-10). Recall #D-037-8.
CODE Lot numbers D960390A and D960390B EXP 4/98.
MANUFACTURER Mikart, Inc., Atlanta, Georgia.
RECALLED BY Manufacturer, by letter on July 2, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Total volume produced and distributed: D960390A, 50,084
bulk tablets repackaged in physicians 2's sample packs;
D960390B,4248 bottles of 100's.
REASON Lot released prior to completed process validation
(Potential blend uniformity failure-chlorpheniramine).
_______________
PRODUCT Dialume Capsules (Aluminum Hydroxide Powder 500 mg),
OTC, labeled for relief of heartburn, sour stomach, or
acid indigestion, in bottles of 100 (NDC #0075-3250-01
and 500 (NDC #0075-3250-02). Recall #D-039-8.
CODE Lot numbers: P63404 and P63609 (100-capsule bottles),
P63506 (500-capsule bottles).
MANUFACTURER Centeon L.L.C., Bradley, Illinois.
RECALLED BY Rhone-Poulenc Rorer Pharmaceuticals, Collegeville,
Pennsylvania, by letter dated October 30, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that very little if any of the 100-count
bottles and a maximum of 300 bottles of 500-count
bottles remained on the market at time of recall
initiation.
REASON Superpotent (16 month stability).
-4-
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-179/181-8.
CODE Unit #KH73644.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on February 14,
1997, and by fax on February 19, 1997. Firm-
initiated recall complete.
DISTRIBUTION Virginia and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected in a manner that
could compromise the sterility of the
collection system.
_______________
PRODUCT Frozen Recovered Plasma. Recall #B-182-8.
CODE Unit #03V03703.
MANUFACTURER American Red Cross, Miami, Florida.
RECALLED BY American Red Cross Blood, Atlanta, Georgia,
by letter on January 7, 1997. Firm-initiated
recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red
Blood Cells that was returned due to clotting.
_______________
PRODUCT Red Blood Cells. Recall #B-200-8.
CODE Unit #6309892.
MANUFACTURER LifeShare Blood Centers, Beaumont, Texas.
RECALLED BY Manufacturer, by fax on April 23, 1997. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood product was collected from a donor who received
rabies vaccine and unit was inappropriately
distributed.
_______________
PRODUCT Source Leukocytes. Recall #B-207-8.
CODE Unit #3157446.
MANUFACTURER Gulf Coast Regional Blood Center,
Houston, Texas.
RECALLED BY Manufacturer, by fax on May 9, 1997. Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product tested reactive for syphilis.
-5-
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-217/218-8.
CODE Unit #03KK10318.
MANUFACTURER American Red Cross, Miami, Florida.
RECALLED BY Manufacturer, by letters dated May 12 and 13,
1997. Firm-initiated recall complete.
DISTRIBUTION a) Florida; b) Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who received
a tattoo within 12 months of donation.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Cryoprecipitated AHF. Recall #B-023-8.
CODE Unit #03GL33240.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on August 20, 1997.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole blood
with an extended collection time.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-036/037-8.
CODE Unit #4822982.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by telephone on December 6, 1996,
followed by letter dated December 18, 1996. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component.
REASON Blood products were distributed after receipt
of information concerning a post donation
illness.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-068/069-8.
CODE Unit #16338-5200.
MANUFACTURER Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY Manufacturer, by letter dated June 23, 1997.
Firm-initiated recall complete.
DISTRIBUTION Mississippi and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
took antibiotics five days prior to donation.
-6-
_______________
PRODUCT Platelets, Pheresis. Recall #B-111-8.
CODE Unit #0561719.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by letter dated October 16,
1996. Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit.
REASON Blood product, for which date and time of placement
into temperature monitored storage was not documented
after receipt, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-208-8.
CODE Unit #21GJ71074.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated November 27,
1996. Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined after receipt of
information concerning a post donation illness.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT SensiCath Optical Sensor Unit used with the SensiCath
Blood Gas Measurement System, a sterile, single-use
disposable device used to measure arterial blood gas
values.
Recall #Z-041-8.
CODE Lots 97-057-03, 97-042-02, 97-043-04,
97-067-01, 97-022-02, 97-028-01, 97-041-09.
MANUFACTURER Optical Sensors, Inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by letter dated March 19, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas, Wisconsin, Illinois, Georgia, Oklahoma, and
Europe.
QUANTITY 163 sensors were distributed.
REASON Inaccurate measurement of p02 due to variability in a
component of the oxygen sensor.
_______________
PRODUCT Marquette Online ABG Module and (fiber-optic)
Interconnect Cable, part of the Marquette Online ABG
Monitoring System.
Recall #Z-042-8.
-7-
CODE All units distributed prior to October 15,
1996.
MANUFACTURER Marquette Electronics, Inc., Milwaukee,
Wisconsin.
RECALLED BY Manufacturer, by letter dated November 15, 1996.
Firm-initiated recall complete.
DISTRIBUTION Maryland, Minnesota, New York, Texas, Germany.
QUANTITY 90 modules were distributed.
REASON Erroneous blood gas values could be reported by some
Online ABG Modules which did not meet accuracy
specifications for the device.
_______________
PRODUCT & Condoms with Nonoxynol. Recall #Z-168/185-8.
CODE Z-168-8 LifeStyles Assorted Colors, 3's
Package Code: 6003
Lot Nos.: 411003000, 502011900, 502018300,
506002200.
LifeStyles Assorted Colors, 1000's
Package Code: 6000
Lot Nos.: 410000900, 410002500, 410004500, 410006400,
410006500, 410010800, 410012700, 410012800, 410016600,
410016700, 410018100, 410018200, 410021400, 410025700,
410025800, 410028000, 410028100, 410029800, 410029900,
410036000, 410036100, 410040600, 410040800, 410040900,
410042800, 410042900, 410044000, 410046000, 410046500,
410048600, 410048700, 410049100, 410049200, 410050600,
410050700, 410051400, 410051500, 410051600, 410051700,
410051900, 410052000, 410052800, 410052900, 410053200,
410053300, 410053400, 410055400, 410055500, 410055600,
410055700, 410056900, 410057000, 410058000, 410058400,
410058500, 410058600, 410058700, 410059000, 410059100,
410059900, 410060000, 410060300, 410060400, 410060500,
411033300, 411033400, 411033500, 411033600, 411034000,
411035000, 411036600, 411036800, 411037300, 411037400,
411039200, 411039300, 411039400, 411039800, 411039900,
411040000, 411040100, 411040600, 411040700, 411041000,
411041100, 411041200, 411042400, 411042500, 411044300,
411044400, 411044500, 411044600, 411044700, 411045200,
411045300, 411048000, 411048100, 411049700, 411049800,
411049900, 411052200, 411052300, 411052400, 411055400,
411055500, 411055700, 412000800, 412001800, 412003300,
412004200, 412005300, 412005400, 412005500, 412005700,
412005800, 412011100, 412024600, 412026000, 412027800,
412028400, 412028800, 412029400, 412031300, 501000400,
501000500, 501003000, 501003100,
-8-
501004300, 501005100, 501005200, 501005400, 501005500,
501005600, 501009700, 501012100, 501012200, 501016100,
501018500, 501018600, 501021100, 501022800, 501022900,
501031500, 501036100, 501036700, 501038600, 501039600,
501039700, 501039800, 501041300, 501041400, 501041500,
501041900, 502000700, 502004400, 502004900, 502007900,
502008500, 502011100, 503032000, 503046000, 504001400,
504001800, 504005600, 504008100, 504008200, 504012900,
504025300.
Z-169-8 LifeStyles Extra Strength, 3's
Package Code: 2103
Lot Nos.: 410021800, 410026400, 410026500, 410051100,
411021500, 411024100, 501006100, 501008100, 501036800,
502028400, 505024300, 609301800, 609301900, 609302600,
609305700, 610301100, 610303100, 610304400, 701300400.
LifeStyles Extra Strength Strips, 3's
Package Code: 2111
Lot No.: 502037900.
LifeStyles Extra Strength Strips, 3's
Package Code: 2131
Lot No.: 610302100.
LifeStyles Extra Strength Strips EXP, 3's
Package Code: 6100
Lot No.: 510044800.
LifeStyles Extra Strength FP, 3's
Package Code: 6103
Lot Nos.: 410000500, 411046800, 503016100, 503016200,
505022100, 505025600, 510044900, 510046200, 510046300,
510049300, 608301600, 608303300, 609302500, 609305500,
610301700, 610301900, 610303900, 701300200, 701300600,
701300800, 702300100.
LifeStyles Extra Strength, 12's
Package Code: 2112
Lot Nos.: 410012400, 410013600, 410013700, 410017100,
410017200, 410028700, 503007100, 505021300, 505024200,
609303600, 609303700, 610300600, 610302800, 610303000,
611300800, 701300700, 702300700, 702301600.
LifeStyles Extra Strength, International, 12's
Package Code: 2112
Lot Nos.: 410011300, 410012400, 611301100.
LifeStyles Extra Strength, Coupon Affixed,
12's, Package Code: 2112
Lot Nos.: 410013600, 410013700, 410028700, 610302600,
610304000 and 610304600.
LifeStyles Extra Strength, Sensormatic Tag, 12's
Package Code: 2112
Lot No.: 702300600.
-9-
LifeStyles Extra Strength, 144's
Package Code: 6144
Lot Nos.: 410018900, 410019000, 410019100, 502023400,
502023500, 502028300, 506011100, 506013300, 507047500,
608302000, 608302300, 608302400, 608303000, 609301300,
610304100, 610304700, 610305300, 610305400, 611300400,
702300900, 702301100, 702301300, 702301400, 702302000,
702302400, 702302600.
LifeStyles Extra Strength, 1000's
Package Code: 2100
Lot Nos.: 411024200, 411024300, 411040200, 411040300,
505000800, 505019000, 506016400, 507035500, 507042100,
507044600, 610301400, 610303200 and 610304500.
LifeStyles Extra Strength Chile, 1000's
Package Code: 2100
Lot No.: 702300200.
LifeStyles Extra Strength, 1000's
Package Code: 6100
Lot Nos.: 410001400, 410003400, 410003500, 410007000,
410007100, 410011400, 410034900, 410036500, 410041100,
410041300, 410042500, 410043200, 410043300, 410046100,
410048200, 410050800, 410052200, 410052300, 410052600,
410052700, 410055100, 410055200, 410057400, 410057800,
410057900, 410059500, 410059700, 410059800, 410061500,
410062200, 410062300, 410062700, 410062800, 411000700,
411001200, 411001300, 411005600, 411006100, 411006200,
411008100, 411008600, 411014800, 411029300, 411032500,
411032900, 411036400, 411039500, 411039600, 411042800,
411042900, 411045100, 411048300, 411050100, 411052600,
411053200, 411056300, 411058400, 412003000, 412006200,
412006300, 412011300, 412013400, 412013500, 412015500,
412023600, 412030000, 501000800, 501002000, 501005700,
501007900, 501008000, 502022500, 502022600, 502024300,
503005200, 503005300, 503007800, 503007900, 503008000,
503025200, 505016100, 505019100, 505034000, 505036700,
505043200, 505045500, 505048200, 505050700, 505053500,
505055900, 506000600, 506003000, 506007700, 507010600,
507013600, 507015500, 507028900, 608301500, 608301700,
608301800, 608301900, 608302100, 608302200, 609300100,
609300200, 609300800, 609301000, 609301100, 609301200,
609301400, 609301500, 609301600, 609302300, 609302800,
609302900, 609303100, 609303900, 609304900, 609305300,
609305600, 610300300, 610300400, 610300500, 610300800,
610300900, 610301000, 610301200,
-10-
610301300, 610301600, 610301800, 610302300, 610302400,
610302500, 610302700, 610304300, 610304800, 610304900,
610305000, 610305200, 611300500, 611300900, 611301200,
611301300, 611301400, 611301500, 702300400, 702300500,
702300800, 702300900, 702301000, 702301800, 702301900,
702302100, 702302200, 702302300, 702302500, 702302700.
Z-170-8 LifeStyles Spermicidally Lubricated,
3's, Package Code: 1803
Lot Nos.: 410012100, 410012200, 410031400, 410058100,
411011600, 411011700, 411011800, 411013500, 411013700,
411015400, 411015500, 411019200, 412008700, 412010400,
412011900, 412012000, 412014000, 412027200, 501018900,
501021500, 501021600, 501025600, 501025700, 501025800,
501028200, 501028400, 502011200, 502011300.
LifeStyles Spermicidally Lubricated EXP, 3's
Package Code: 5500
Lot Nos.: 611301800, 611301900, 611302000, 611302300,
611302700, 611302900, 611304500, 611304800, 611305100,
612302200.
LifeStyles Spermicidally Lubricated 73 mm FP, 3's, Package
Code: 5503
Lot Nos.: 410024600, 410032500, 410033900, 410038200,
410038300, 410050100, 410064100, 411047200, 411055100,
412000700, 412005100, 501004700, 501008900, 510038700,
611302600, 612301800.
LifeStyles Spermicidally Lubricated, 12's
Package Code: 1812
Lot Nos.: 410011000, 410012900, 410035600, 410057100,
410062100, 411000500, 411000600, 411003700, 411003800,
411005400, 411005500, 411007900, 411008000, 411010700,
411023600, 411038900, 411042300, 411050700, 411050800,
411053400, 412016900, 412017000, 412021300, 412021400,
412021900, 412022000, 412023500, 412027700, 501008600,
501009400, 501016500, 501018700, 501018800, 501031200,
501031400, 502008700, 502040200, 503004700, 503007200,
506058400.
LifeStyles Spermicidally Lubricated, 15's
Package Code: 1812
Lot Nos.: 410006600 and 410010900.
LifeStyles Spermicidally Lubricated 73 mm,
12's, Package Code: 5512
Lot Nos.: 410025100, 410027800, 410032800, 410034300,
410039300, 410043700, 410045300, 412009800, 501026600,
502021000.
-11-
LifeStyles Spermicidally Lubricated Strips,
144's, Package Code: 5544
Lot Nos.: 410013100, 410013200, 410018500, 411011000,
411033700, 411038800, 412006400, 412006500, 508046100.
LifeStyles Spermicidally Lubricated, 1000's
Package Code: 1800
Lot Nos.: 410002600 and 501037700.
LifeStyles Spermicidally Lubricated, 1000's
Package Code: 5500
Lot Nos.: 410001100, 410002100, 410002800, 410002900,
410006700, 410006800, 410013000, 410016800, 410018300,
410018400, 410025900, 410026000, 410028200, 410030000,
410030100, 410030200, 410030300, 410030400, 410031500,
410031600, 410033000, 410035700, 410036200, 410036300,
410036400, 410036600, 410036700, 410037600, 410040500,
410042200, 410042300, 410044500, 410044600, 410044700,
410049300, 410058800, 410058900, 410061600, 410061700,
410061800, 410061900, 410062900, 410063000, 410063300,
410063500, 410063600, 411000100, 411000200, 411000300,
411000400, 411001500, 411002000, 411002100, 411005100,
411006800, 411007500, 411007600, 411009300, 411009400,
411010300, 411012100, 411012800, 411012900, 411014100,
411014200, 411014300, 411014400, 411015800, 411015900,
411017800, 411019400, 411020400, 411020500, 411022200,
411022300, 411023200, 411025200, 411025700, 411025800,
411026200, 411027400, 411028600, 411028700, 411029100,
411029200, 411030000, 411031100, 411031200, 411031600,
411032200, 411032400, 411033800, 411033900, 411034700,
411034900, 411035400, 411035500, 411035600, 411036100,
411036200, 411036300, 411037500, 411044800, 411044900,
411045000, 411045500, 411045600, 411048200, 411048600,
411048700, 411050000, 411050300, 411050400, 411052500,
411052900, 411053000, 411053100, 412002000, 412005900,
412006000, 412006100, 412007100, 412007200, 412008200,
412008300, 412011200, 412013200, 412015300, 412015400,
412018400, 412018600, 412018700, 412019300, 412019600,
412019700, 412020300, 412020500, 412022100, 412032700,
412032800, 412032900, 501001900, 501040100, 502019300,
503002000, 503002100, 503002600, 506064400, 510002400,
611301600, 611302200, 611302400, 611302500, 611303000,
611303200, 611304100, 611304600, 612301500, 612303400.
Z-171-8 LifeStyles Ultra Sensitive with
Spermicide, 12's, Package Code: 2012
Lot Nos.: 410022300 and 410022400.
-12-
LifeStyles Ultra Sensitive with Spermicide,
12's, Package Code: 2014
Lot Nos.: 410022300 and 504025600.
Z-172-8 LifeStyles Ultra-Sure Strips, 4's
Package Code: 6716
Lot No.: 501026100.
Z-173-8 LifeStyles Vibra Ribbed, 3's
Package Code: 1403
Lot Nos.: 410017500, 410017600, 410031300, 411012200,
411029900, 606350500, 702353200, 702354700, 703351100,
703355500.
LifeStyles Vibra Ribbed, 12's
Package Code: 1412
Lot Nos.: 410007700, 410011900, 410012000, 410014200,
410014300, 411001800, 411001900, 412002100, 412006600,
412006700, 501016200, 501039900, 605352300, 701350100,
704350800.
LifeStyles Vibra Ribbed SMTC, 12's
Package Code: 1412
Lot Nos.: 702353900, 702354600, 702355400,
703350100, 703350400.
LifeStyles Vibra Ribbed, 1000's
Package Code: 1400
Lot Nos.: 410007600, 411029800, 412006800,
501016300, 501016400, 702354500.
LifeStyles Vibra Ribbed DOKA, 7200's
Package Code: 4006
Lot No.: 704350400.
Z-174-8 Prime Spermicidal Strips FP, 3's
Package Code: 3503
Lot Nos.: 410000400, 410005000, 410056100, 410061000,
411012500, 411047500, 412000200, 412002500, 412009100,
412033000, 508076200, 611303800.
Prime Spermicidal Strips, 1000's
Package Code: 3500
Lot Nos.: 410008800, 410010200, 410015100, 410016200,
410023400, 410032700, 410038700, 410065100, 411019700,
411037800, 411042100, 505026000, 612300600, 612301300.
Prime Espermicida, 1000's
Package Code: 3505
Lot No.: 612301100.
Z-175-8 Contempo Intensity Strips, 1000's
Package Code: 4600
Lot No.: 411026100.
Z-176-8 Contempo Power Play Extra Strong,
3's, Package Code: 4530
-13-
Lot Nos.: 410009000, 410015200, 410021000, 502007100,
503044400, 505016900, 505020000, 505055200, 505057800,
506049700, 506052200, 608301400, 609300400, 609305200,
609305400, 610300700, 610301500, 610302000, 610303600,
701300500.
Contempo Power Play Extra Strong, 3's
Package Code: 4531
Lot No.: 510038600.
Contempo Power Play Extra Strong, 6's
Package Code: 4542
Lot No.: 609304800.
Contempo Power Play Extra Strong, 1000's
Package Code: 4542
Lot Nos.: 410010500, 410023700, 410023800, 410023900,
608301600, 609300500, 609300900, 609302400.
Z-177-8 Affinity Extra Strong Strips, 4's
Package Code: 6745
Lot Nos.: 410036800, 410036900, 504032300, 504032400,
504032500, 504032600, 504038100, 504038200, 504047600,
504047700, 505036800, 505040000, 505040100, 505045600,
505050800, 506000700, 506003100, 507031600, 507033100,
507033400, 507038000, 507042500, 507048500.
Z-178-8 Mates Colour Strips, 2's
Package Code: 6905
Lot No.: 505038900.
Z-179-8 Mates Natural Strips, 2's
Package Code: 6903
Lot Nos.: 410023100, 410024300, 410038000, 410039100,
410047300, 410049900, 410053800, 410054400, 410054600,
410054900, 410056200, 410056500, 410061100, 410061400,
411007200, 411019600, 411022800, 411028000, 411028400,
411034200, 411034500, 411037900, 411038500, 411041300,
411041900, 411046900, 411047600, 411047900, 411051600,
411053900, 411054300, 412004800, 412011000, 412023800,
412023900, 412024000, 505023000, 505047100.
Z-180-8 Mates Ribbed Strips, 2's
Package Code: 6904
Lot Nos.: 501013400 and 505023100.
Mates Ribbed Strips, 6's
Package Code: 6904
Lot Nos.: 605350100, 605352100, 605352200, 605352400,
606300900, 701350300, 702350800, 702354000, 702354200,
702354400, 702355000, 703353500, 703353600.
Z-181-8 Mates Super Strong Strips, 2's
Package Code: 6907
Lot Nos.: 410020500, 410060700, 503038500, 504015400.
-14-
Z-182-8 Mates Ultra Safe Strips, 2's
Package Code: 6906
Lot Nos.: 410000300, 410008400, 410009700, 410015800,
410060900, 411002700, 411003200, 412009900.
Mates Ultra Safe Strips, 6's
Package Code: 6906
Lot Nos.: 611302100, 611303100, 611304500, 611304900,
611305000, 612301700, 612302600.
Z-183-8 Plain, C52, Spermicidally
Lubricated, 3's, Package Code: 1244
Lot Nos.: 410041600, 410043600, 410043800, 410046400,
503036200.
Z-184-8 Safety Shaped, 10's
Package Code: 5023
Lot No.: 612302700.
Z-185-8 Sultan Spermicidal, 3's
Package Code: 0657
Lot Nos.: 703353800 and 703354900.
Notes: 1.) Some of the above products were
for export only.
2.) Some packages may have a "0" preceding
the lot number.
3.) The packages bear expiration dates which
are three (3) years from the date of
application of the spermicidal lubricant and
packaging.
MANUFACTURER Ansell, Inc., Dothan, Alabama, and Troy,
Alabama.
RECALLED BY Ansell, Inc., Dothan, Alabama, by letters mailed
beginning on October 17, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 57 million condoms were distributed.
REASON The devices may have defects which could cause
breakage during use.
_______________
PRODUCT 5.5mm Outside Diameter Outer Cannula, Catalog No.
C7212, (a component of the C7210 APEX Pressure Sensing
Cannula System). Recall #Z-186-7.
CODE The cannula component under recall has a lot number
permanently etched on it and the following component lot
numbers are involved (The kit must be opened to see lot
number):
L.SB74866 L.SB74865 L.SC75746
L.SC75754 L.SB74874 L.SB75087
L.SC76106 L.SB75467 L.SB74867
L.SB75086 L.SC76107 L.SD77590
-15-
L.SB75083 L.SB75477 L.SB75475
L.SD77582
The APEX Pressure Sensing Cannula System Kits
which may have the recalled component lot
numbers within them are as follows:
SB75395 SC75827 SC76353 SD77299
SE78618 SB75594 SC75828 SD76881
SD77837 SB75595 SC75829 SD76883
SE78427 SC75596 SC76133 SD76900
SE78140.
MANUFACTURER Shutt Medical Technologies, San Dimas,
California.
RECALLED BY Linvatec, Inc., Largo, Florida, by letter on
September 8, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Michigan, California, New York, Montana, New
Jersey, Illinois, Minnesota, Ohio, Idaho,
Tennessee, Wisconsin, New Mexico, Utah, Australia,
Belgium, Canada, Germany, England.
QUANTITY 65 systems were distributed.
REASON The pressure port of the cannula is subject to
blockage.
_______________
PRODUCT Abbott Laboratories autotransfusion apparatus:
a) Receptal A.T.S. Interface Kit, List #44000
b) Receptal A.T.S. Trauma Liner Assembly, - List #44002
c) Receptal A.T.S. Sterile Blood Liner, - List #43484
d) Receptaseal Thoracic Autologous Blood Transfusion Kit -
List #43482.
Recall #Z-187/190-8.
CODE Lot numbers: a) 21-328-SN, 23-330-SN, 25-405-SN, 30-204-SN;
b) 18-080-SN, 19-096-SN, 20-015-SN, 21-329-SN, 22-172-SN,
23-331-SN, 24-192-SN, 26-239-SN, 29-315-SN, 30-205-SN,
31-046-SN, 32-249-SN;
c) 19-092-SN, 22-170-SN;
d) 18-077-SN, 20-013-SN, 21-326-SN, 22-168-SN, 23-328-SN,
24-293-SN, 25-404-SN, 27-320-SN, 30-202-SN, 31-044-SN.
MANUFACTURER Abbott laboratories, Salt Lake City, Utah.
RECALLED BY Abbott Laboratories, Abbott Park, Illinois, by
letter dated October 23, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimated that 12,000 units remained on market at
time of recall initiation.
REASON The misassembled devices are not adequately
filtering the blood.
-16-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT MicroTrak II Chlamydia Enzyme Immunoassay, Catalog No.
8H709UL, in vitro diagnostic product. Per the package
insert, "The MicroTrakr II Chlamydia EIA is an enzyme
immunoassay (EIA) intended for in vitro diagnostic use
in the qualitative detection of Chlamydia in female
endocervical, male urethral, and male urine specimens,
and ocular specimens from symptomatic patients."
Recall #Z-153-8.
CODE Lot Nos. JAJ, JAK, and JAL.
MANUFACTURER Dade Behring, Inc., Cupertino, California.
RECALLED BY Manufacturer, by letter on December 20, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 2,071 kits of lot JAJ, 1,542 kits of lot JAK, and 20
kits of lot JAL were distributed.
REASON The enzyme conjugate is contaminated with excessive
bioburden.
_______________
PRODUCT COMATIC Factor VIII, Art. #82 25 85, in-vitro
diagnostic test kits, . Recall #Z-191-8.
CODE Lot numbers: 2957, X3119, X3308, X3532, X3604, X3677.
MANUFACTURER Chromogenix AB, Sweden.
RECALLED BY DiaPharma Group, Inc., Franklin, Ohio, by letter
mailed on November 4, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Colorado, Michigan, Massachusetts, Pennsylvania,
California, Minnesota, Wisconsin, North Carolina,
Missouri, New Jersey, Florida, New York.
QUANTITY 223 kits were distributed.
REASON The absorbance value limits for the standard curve as
listed in the calculation section of the package insert
are incorrect.
_______________
PRODUCT Innofluor Tobramycin Calibrator Set, intended for the
quantitative determination of total tobramycin in serum
for therapeutic drug monitoring by fluorescence
polarization immunoassay. Recall #Z-192-8.
CODE Catalog #41021, Lot #25954.
MANUFACTURER Oxis International, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by telephone on July 7, 1997, and by
letter. Firm-initiated recall complete.
-17-
DISTRIBUTION Alabama, Arkansas, California, Florida, Indiana,
Massachusetts, Minnesota, Ohio, Oklahoma, England,
Belgium, France.
QUANTITY 43 sets were distributed.
REASON The device produces a B-C spa on the calibration curve
which is less than the instrument parameter needed for
a valid calibration curve.
-18-
END OF ENFORCEMENT REPORT FOR NOVEMBER 26, 1997. BLANK PAGES MAY FOLLOW.
####
End of Enforcement Report for
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