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.
ENFORCE
09/07/1994
Recalls and Field Corrections: Foods -- Class II -- 09/07/1994
September 7, 1994 94-36
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
========================
______________
PRODUCT Tofutti Brand Nondairy frozen dessert,
vanilla flavored. Recall #F-765-4.
CODE 1413/42097.
MANUFACTURER Kemp's Foods, Inc., Lancaster, Pennsylvania
RECALLED BY Tofutti Brands, Inc., Cranford, New Jersey by letter
July 27, 1994. Firm-initiated recall ongoing.
DISTRIBUTION California, Texas, New York, Illinois, New Hampshire,
Georgia, Ohio.
QUANTITY 1,381 containers were distributed. Firm estimates little if
any remains on the market.
REASON The product is labeled as a nondairy frozen dessert and
contains lactose.
______________
PRODUCT Pistachio N' Cream Ice Cream. Recall #F-817-4.
CODE All codes
MANUFACTURER West Lynn Creamery, Lynn, Massachusetts.
RECALLED BY Albert Essay Ice Cream Company, Southampton, New York by
visit with followup letter August 15, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION New York.
QUANTITY 60 sleeves were distributed. Each sleeve contains 8 pints.
REASON The product contains undeclared FD&C Yellow #5 and FD&C Blue
#1.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
=====================
______________
PRODUCT Sunrise brand Mineral Free Water in plastic jugs,
Recall #F-752-4.
CODE 092594.
MANUFACTURER Arcadia Dairy Farm Inc., Arden, North Carolina
RECALLED BY Manufacturer, by telephone with follow-up letter April 21,
1994. Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1,024 jugs were distributed.
REASON The product is contaminated with coliform.
______________
PRODUCT Shop n Save Orange Juice from Concentrate. Recall #F-766-4.
CODE Sell by 8/12 A3947, Sell by 8/15 - A3947, Sell by 8/16 -
A3947.
MANUFACTURER Tamarack Farms Dairy, Newark, Ohio.
RECALLED BY SuperValu, Inc., Chaska, Minnesota by memorandum August 8,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Maryland, Ohio, Pennsylvania, West Virginia.
QUANTITY 11,976 cases/6 bottles per case were distributed.
REASON The product is contaminated with mold.
______________
PRODUCT Frozen Tuna Steaks. Recall #F-816-4.
CODE AL-23.
MANUFACTURER Long Beach Enterprises (dba Sea One Seafoods), Santa Fe
Springs, California.
RECALLED BY Food Services of America, Kent-Washington by telephone
July 8, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Washington state, Alaska.
QUANTITY 65/10 pound cases were distributed.
REASON The product is decomposed.
-2-
______________
PRODUCT Mint Chocolate Chip Ice Cream. Recall #F-818-4.
CODE All lots.
MANUFACTURER West Lynn Creamery, Lynn, Massachusetts.
RECALLED BY Albert Essay Ice Cream Company, Southampton, New York by
letter August 15, 1994. Firm-initiated recall ongoing.
DISTRIBUTION 28 sleeves were distributed.
QUANTITY New York.
REASON The product contains undeclared FD&C Blue #1.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=======================
______________
PRODUCT CompuMed brand "TMP/SMZ Oral Suspension packed in 100 ml,
120 ml, 150, 180 ml, and 200 ml bottles. Recall #D-376-4.
CODE RL3711-A, RL3711, Exp date 05-96.
MANUFACTURER Barre-National, Inc., Baltimore, Maryland
RECALLED BY CompuMed Inc., Pharmaceuticals, Harahan, Louisiana
(repacker) by letter on or about August 10, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Alabama, California, Georgia, Louisiana, Maryland,
Mississippi, Missouri, New York, Ohio, South Carolina,
Tennessee, Virginia, Wyoming.
QUANTITY 860 bottles were distributed.
REASON Subpotency of trimethoprim ingredient.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
======================
______________
PRODUCT Norton brand Chemdal-HD Plus (Hydrocodone Bitartrate, 2.5
mg; Phenylephrine Hydrochloride; 5mg; Chlorpheniramine
Maleate, 2mg. Recall #D-377-4.
CODE Lot #7617.
MANUFACTURER H. N. Norton Company, Shreveport, Louisiana.
RECALLED BY Manufacturer by telephone and followup letter July 20, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,123 bottles were distributed.
REASON Subpotency.
______________
PRODUCT Amiloride Hydrochloride and Hydrochlorothiazide Tablets,
USP, 5 mg/50mg packaged in 100 tablets per box, an Rx oral
drug for the treatment of hypertension. Recall #D-378-4.
CODE Lot #'s 3I249, 3M680, 4A044, 4C389.
-3-
MANUFACTURER Biocraft laboratories, Inc., Elmwood Park, New Jersey.
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois (repacker) by
letter August 24, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,826 cartons of 100 unit dose were distributed. Firm
estimates that 35% of the product remains on the market.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
=====================
______________
PRODUCT (a) Platelets; (b) Fresh Frozen Plasma. Recall #B-440/441-4.
CODE Unit number KG50275 for both platelets and fresh frozen
plasma.
MANUFACTURER Central Blood Bank, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer by telephone February 19, 1994. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 2 units.
REASON Blood products, corresponding to Red Blood Cells
contaminated with Staphylococcus aureus distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Baxter Fenwal Transfer Packs and Plasma Transfer Sets;
Rx device used to transfer blood products:
(a) Baxter Fenwal Transfer Packs
(i) product 4R2001A: Baxter Fenwal Transfer Pack Container,
150 ml, with Coupler, 12 units per carton
(ii) product 4R2004: Baxter Fenwal Quadruple Transfer Pack
Container, 150 ml, with Coupler, 6 units per carton
(iii) product 4R2014A: Baxter Fenwal Transfer Pack
Container, 300 ml, with Coupler, 12 units per carton
(iv) product code C4R2016 - European labeling
(v) product R4R2074: Baxter Fenwal Transfer Pack, 400 ml,
with Coupler - European labeling and distribution only
(vi) product 4R2023: Baxter Fenwal Transfer Pack Container,
600 ml, with Coupler, 12 units per carton
(vii) product R4R2021 - European labeling
(viii) product C4R2026 - European labeling
-4- (ix) product 4R2027: Baxter Fenwal Transfer Pack Container,
600 ml, with 8 Couplers, 1 unit per carton
(x) product 4R2054: Baxter Fenwal Transfer Pack Container,
800 ml, with 2 Couplers and no Outlet Ports, 12 units per
carton
(xi) product R4R2053 - European labeling
(xii) product 4R2055: Baxter Fenwal Transfer Pack Container,
800 ml, with 2 Couplers and Outlet Ports, 12 units per
carton
(xiii) product 4R2032: Baxter Fenwal Transfer Pack
Container, 1000 ml, with Coupler, 12 units per carton
(xiv) product R4R2031 - European labeling
(xv) product 4R2041A: Baxter Fenwal Transfer Pack Container,
2000 ml, with Coupler, 1 unit per carton
(xvi) product 4R2422: Baxter Fenwal Cryocyte Pack Freezing
Container, 2000 ml, 1 unit per carton
(b) Baxter Fenwal Plasma Transfer Sets
(i) product 4C2240: Baxter Fenwal Plasma Transfer Sets with
Spike and Needle Adapter, 2 units per carton
(ii) product 4C2243: Baxter Fenwal Plasma Transfer Sets with
Two Spikes, 2 units per carton
(iii) product 4C2244: Baxter Fenwal Plasma Transfer Sets
with Spike and Stopper Puncture Needle, 2 units per carton
Recall #B-443/444-4.
CODE (a) Transfer Packs:
(i) product 4R2001A: lots A93K19014R, A93K25011R,
A94B04021R, A94C01033R
(ii) product 4R2004:lots A93J26029R, A93K11011R, A93K20012R,
A94A31018R, A94B28012R
(iii) product 4R2014A: lots A93I20015R, A93I28018R,
A93J14025R, A93K01012R, A93K01020R, A93K04016R, A93K10013R,
A93K12027R, A94A14014R, A94A17017R, A94B07016R, A94C01017R
(iv) product code C4R2016 - European labeling, lot
A94A25036R
(v) product R4R2074: European labeling, lots A93I27010R,
A93J27019R
(vi) product 4R2023: lots A93J06021R, A93K04024R,
A93K12019R, A93L02026R, A94A20011R, A94B02017R
(vii) product R4R2021 - European labeling, lots A93I22011R,
A93J21020R
(viii) product C4R2026 - European labeling, lots A94A25010R,
A94B23021R, A94C02015R
(ix) product 4R2027: lots A93J21012R, A94A27024R, A94B15027R
(x) product 4R2054: lot A93J14017R
(xi) product R4R2053 - European labeling, lot A94B15019R
(xii) product 4R2055: lots A93I23019R, A93J25021R,
-5- A93J29015R, A93K23024R, A93L07025R, A94A31026R, A94B23013R
(xiii) product 4R2032: lots A93J07011R, A93K27025R,
A94B03015R
(xiv) product R4R2031 - European labeling, lot A93I23027R
(xv) product 4R2041A: lots A93J13019R, A93K29021R,
A94B28020R
(xvi) product 4R2422: lots A93J26011R, A93J29023R,
A94B14020R
(b) Transfer sets:
(i) product 4C2240: lots U210377R, U213025R, U221101R,
U226225R, U234484R, U237263R, U237412R, U239087R
(ii) product 4C2243: lots U201921R, U201897R, U203893R,
U204149R, U214841R, U226100R, U227603R, U232256R,
U234351R, U235713R
(iii) product 4C2244: lots U221010R, U224899R, U230227R.
MANUFACTURER (a) Baxter S.A. Fenwal Division, Parque Industrial De Haina,
Haina San Cristobal, Republica Dominicana; (b) Baxter
Healthcare Corporation of Puerto Rico, Aibonito, Puerto
Rico.
RECALLED BY Baxter Healthcare Corporation, Biotech Fenwal Division,
Deerfield, Illinois, by letter July 6, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 923,000 packs and 474,000 sets were
distributed; firm estimates that little product remained on
market at time of recall.
REASON Transfer packs and Plasma Transfer Sets, which on numerous
occasions the tubing of the device separated from the
coupler sub-assembly, were distributed.
______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma; (c) Recovered
Plasma. Recall #B-445/447-4.
CODE Unit numbers: (a) M59173, M59859, M59863, M60207, M60741,
M60743, M60855, M60860, M60879, M62679, T63336, T64118,
T64359, T64723, T65400, T65674, T66203, T66502, T66546; (b)
M59859, M59863, T63336, T64118, T66203, T66546; (c) M59173,
M60207, M60741, M60743, M60855, M60860, M60879, M62679,
T64359, T64723, T65400, T66502.
MANUFACTURER Topeka Blood Bank, Topeka, Kansas.
RECALLED BY Manufacturer by letters January 25, 1994 and February 24,
1994. Firm-initiated recall ongoing.
DISTRIBUTION (a) Massachusetts, Florida, Kansas, Alabama; (b) Kansas,
Missouri; (c) Florida.
QUANTITY (a) 19 units; (b) 6 units; (c) 12 units were distributed.
REASON Blood products, collected from donors whose health history
screening was inadequately performed, were distributed.
-6- ______________
PRODUCT
Source Plasma. Recall #B-454-4.
CODE Units numbers: XA53864, XA54165, XA55438, XA55806, XA56409,
XA56447, XA56745, XA56789, XA57665, XA58413, XA59562,
XA59802, XA60350, XA60543, XA60751, XA60863, XA61417,
XA61588, XA61777, XA61948, XA62379, XA62600, XA62902,
XA63498, XA63839, XA64592, XA64897, XA69449, XA69786,
XA70354, XA70907, XA71578, XA71632, XA71882, XA72998,
XA74699, XA74116, XA75167, XA75915, XA76303, XA77323,
XA77854, XA78295, XA81914, XA82199, XA82758, XA83197,
XA83800, XA84002, XA84957, XA88089, XA88722, XA92060.
MANUFACTURER Community Bio-Resources, Inc./Immuno-U.S., Inc., Birmingham,
Alabama.
RECALLED BY Community Bio-Resources, Inc., Birmingham, Alabama by
letters dated January 17 & 28, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Maine, Austria.
QUANTITY 54 units.
REASON Blood products, collected from ineligible donors due to
intravenous (IV) drug use, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Howmedica Dall-Miles Trochanter Cable Grip System, used to
provide fixation of the greater trochanter following
osteotomy in total hip arthroplasty. Recall #Z-1105-4.
CODE Lot numbers BTIYBA, BTIYCA, Catalog #6704-8-020.
MANUFACTURER Howmedica U.S.A. (Medical Device Manufacturer, repacker,
relabeler) Howmedica Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer by telephone May 19 and May 24, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Ireland.
QUANTITY 200 cables were distributed.
REASON The device package is labeled for a 2 mm diameter cable,
when in fact a 1.6 m diameter cable is actually in the
package.
______________
PRODUCT Battery Cable for Delphin II Centrifugal Pump.
Recall #Z-1217.
CODE Not coded, Part #78-8067-3763-7.
MANUFACTURER Sarns 3M Health Care, Ann Arbor, Michigan.
RECALLED BY Manufacturer by telephone or about October 6, 1993. Firm-
initiated recall complete.
DISTRIBUTION South Carolina, Ohio, Minnesota, Colorado.
QUANTITY 10 cables were distributed.
REASON Cables lacked necessary jumper which relays the battery
signal to the digital display and audio alarm systems of the
device resulting in the failure of the device to function as
intended.
-7-
______________
PRODUCT (A) Patient Monitors as follows:
(1) Horizon XL
(2) Mercury
(3) Horizon 2000
(4) Horizon 3000
(5) MR 1200 & 1300 Series Monitors
(6) Horizon 1100
(7) Microsolo (425-330 Module)
(8) 743 Neonatal Portable Monitor and 744 Portable
Monitors; (9) ECG and heart Rate Module, No. 425-010
(10) Respiration Module, No. 427-010.
Non-APNEA Monitors:
(1) Series 419 ECG Telemetry
(2) MG Series 936 Cardio/Pak Defibrillator
(3) Cardio/Pak 100 Defibrillator (310-010-010)
(4) Cardio/Pak 2000 Defibrillator (310-200-010)
(5) Cardio/Rite :Model 350 Potable EKG
(6) Model #S 740, 741, 742 Portable Monitors
(7) Portascope 931
(8) Horizon 1000
(9) Horizon 9000 Cardiac Cath Lab System
(10) Cath Lab 12 Lead EKG Option
(11) 910 ECG Modules;
(B) Patient Cables:
800-030-030 800-030-040
800-030-100 800-030-380
800-030-300 800-030-390
800-030-360 800-030-400
800-030-370 800-030-460
800-030-372 800-030-480
800-030-500
(D) Lead Wires:
800-030-110, -120, -130, -140, -150, -152
800-030-210, -220, -230, -240 -250, -252
800-030-310, -320, -330, -340, -340, -352
800-030-410, -420, -430, -440, -450, -452
800-030-510, -520, -530, -540, -550, -552
800-030-610, -620, -630, -640, -650, -652.
Recall #Z-1229/1231-4
CODE All serial and lot numbers.
MANUFACTURER Mennen Medical Corporation, Clarence, New York.
RECALLED BY Manufacturer by letter August 4, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, international.
-8- QUANTITY Unknown.
REASON Labeling fails to provide adequate directions for use and
the devices pose an unwarranted risk of injury to patients,
because the devices are not labeled to warrant against the
hazards of unprotected electrode lead wires being connected
to electrical power sources.
______________
PRODUCT Howmedica Grosse & Kempf Left Femoral Locking Nail, 12 mm
diameter, 36 cm length. Recall #Z-1237-4.
CODE Lot numbers BTEKB, BTEKC, Catalog #3515-1-236
MANUFACTURER Howmedica GMBH, Kiel, Germany.
RECALLED BY Howmedica Inc., Rutherford, New Jersey by telephone June 9
and June 13, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 10 packages were distributed.
REASON The device package is labeled for a left oriented nail, when
in fact a right oriented nail is actually in the package.
______________
PRODUCT Howmedica Gamma Locking Nail 14 mm 125o stainless steel
packaged individually within a tyvek/poly blister pack.
Recall #Z-1238-4.
CODE Lot number BHFLA, Catalog #3370-0-425.
MANUFACTURER Howmedica GMBH, Kiel, Germany.
RECALLED BY Howmedica Inc., Rutherford, New Jersey by telephone May 12
and June 9, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 10 each were distributed.
REASON The device package is labeled for a 125o orientation, while
a 130o nail is actually in the package.
______________
PRODUCT Endosonics Ultrasound Imaging Catheters, used for diagnostic
intravascular imaging in the peripheral and coronary
vasculature:
(a) Vision 3.5F Model 54700;
(b) Vision F/X Model 52700. Recall #Z-1278/1279-4.
CODE (a) Serial Nos. 05394319, 07794304, 08194351, 09694312,
10194305, 10294332, 10394309, 10694309, 10894303, 10894340,
10994305, 10994323, 11094306, 11094308, 34993316.
(b) Serial Nos. 07594319, 08394334, 10894341, 10994322,
11094303, 11093405, 11094311, 11094322, 11194303, 11194314,
11194318, 11194319, 11194322, 11194338, 11294315, 11394304,
11394315, 11594301, 11594302, 11594306, 11594309, 11594315,
11594317, 11594318, 11594321, 11694312, 11794320.
-9- MANUFACTURER Endosonics Corporation, Pleasanton, California.
RECALLED BY Endosonics Corporation, Rancho Cordova, California, by
telephone or in person on June 15, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Georgia, North Carolina, Tennessee, Texas, Washington state,
Germany.
QUANTITY 64 units were distributed.
REASON The catheters failed the minimum bond strength requirement
due to use of an unauthorized assembly line procedure.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
=====================
______________
PRODUCT Dade Fibrinogen Degradation Detection Set, in vitro
diagnostic product which determines the presence of fdp in
serum or urine. Recall #Z-1322.
CODE Lot #FDPK-344, FDPK-345, (kit contains Fibroninogen Control
lot #FC-89), Catalog #B4233-10, Exp. date 9/30/94.
MANUFACTURER Baxter Diagnostic of Puerto Rico Inc., Aguada, Puerto, Rico
RECALLED BY Baxter Diagnostic Inc., Miami, Florida by letter April 8,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 1,060 vials were distributed.
REASON The fibrinogen control was giving a negative instead of a
positive reaction when diluted 1:5 for the qualitative or
semi-quantitative testing.
______________
PRODUCT (a) Dade Fibrinogen Degradation (FDP) Detection Set,
(b) Dade Latex Anti-Fibrinogen Suspension.
Recall #Z-1323/1324-4.
CODE Lot numbers: (a) FDPK-326/329, 330/332, 334/338, 343/345.
Catalog #B4233-10; (b) LAF-261/270, 272/275,
Catalog #B4233-11 .
MANUFACTURER Baxter Diagnostics of Puerto Rico, Aguada, Puerto, Rico.
RECALLED BY Baxter Diagnostics, Inc., Miami, Florida. by letter April 8,
1994 and June 8, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY (a) 5,577 sets; (b) 17,571 vials were distributed.
REASON (a) The fibrinogen (FDP) control was giving a positive
reaction when diluted 1:20 for use as a negative control.
(b) the product had a contaminant that could cause
precipitation, which caused increased sensitivity by giving
a weakly positive reaction when used to prepare the negative
control.
CORRECTION:
August 24, 1994 Enforcement Report, Recall #Z115/116-4
should read: Code: (a) All serial numbers lower than 8579
instead of 859. The 7 was inadvertently left out.
-10-
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT Purina Mills brand Start & Grow MP 0.0125%, in 25 pound and
50 pound bags, medicated, complete and balanced poultry
feed. Recall V-069-4.
CODE Lot numbers: 6043E3I (25 pound bags), 6043E21 (50 pound
bags).
MANUFACTURER Purina Mills, Inc., Lubbock, Texas.
RECALLED BY Manufacturer, by telephone June 13, 1994. Firm-initiated
recall complete.
DISTRIBUTiON New Mexico, Texas.
QUANTITY Approximately 500 25-pound bags and 3,000 50-pound bags were
distributed; firm estimates none remains on the market.
REASON Mislabeled. A non-medicated feed bag was used by mistake
for the medicated product.
####
-11- END OF ENFORCEMENT REPORT FOR SEPTEMBER 7, 1994. BLANK PAGES MAY
FOLLOW.