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
02/10/1993
Recalls and Field Corrections: Foods - Class I -- 02/10/1993
93-6
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
PRODUCT Ducal brand canned fruit and vegetable products:
(a) Refried Black Beans, (Frijol Negro), in 10.5 ounce and 16
ounce cans;
(b) Refried Red Beans, (Frijol Rojo), in 10.5 ounce and 16
ounce cans;
(c) Hot Jalapeno Peppers, Sliced (Chiles Jalapenos (Rodajas)),
in 5-1/2 ounce cans;
(d) Hot Jalapeno Peppers, Halves (Chiles Jalapenos (Mitades)),
in 5-1/2 ounce cans;
(e) Mango Nectar (Mango), in 5-1/2 ounce cans;
(g) Blended Fruit Cocktail (Coctel de Frutas), in 5-1/2 ounce
cans;
(h) Guava Nectar (Guayaba), in 5-1/2 ounce cans;
(i) Vegetable Juice (Jugo de Vegetles), in 5 1/2 ounce cans);
(j) Papaya Nectar, in 5-1/2 ounce cans;
(k) Peach Nectar (Melocoton), in 5-1/2 ounce cans;
(l) Apple Nectar (Manzana) Nectar, in 5-1/2 ounce cans;
(m) Pear Nectar (pera) Nectar, in 5-1/2 ounce cans;
(n) Pineapple Nectar (Pina) Nectar, in 5-1/2 ounce cans;
(o) Corn Tamale (Tamal de Masa), in 5-1/2 ounce cans.
Recall #F-187/200-3.
CODE All lots bearing a date code of 08304 and earlier.
MANUFACTURER Alimentos Kern de Guatemala, S.A., Guatemala City, Guatemala.
RECALLED BY Manufacturer, by telephone November 17, 1992, followed by
letter dated November 18, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Florida, New York, Idaho, California.
QUANTITY Firm estimates 2,000 cases remained on the market when recall
was initiated.
REASON Product is contaminated with lead.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Iberia brand Soursop Nectar, also known as Guanabana, a fruit
juice, in 7.1 ounce, 12 ounce and 46 ounce cans.
Recall #F-214-3.
CODE All lots.
MANUFACTURER Caribex Dominicana, SA, Santo Domingo, Dominican Republic.
RECALLED BY Iberia Foods of Florida, Inc., Miami, Florida, by letter
December 23, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Florida.
QUANTITY 835 cases were distributed.
REASON The product contains excessive levels of tin.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Pentothal Ready-to-Mix Syringe, 500 mg, 2.5% (25 mg/ml,
Thiopental Sodium for Injection, USP, used as anesthesia.
Recall #D-113-3.
CODE Lot #64-604-R1.
MANUFACTURER Abbott Laboratories, Hospital Products Division, Rocky Mount,
North Carolina.
RECALLED BY Abbott Laboratories, hHspital Products Division, Abbott Park,
Illinois, by letter October 14, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 18,225 units were distributed; firm estimates that little
product remains on the market.
REASON Some correctly labeled syringes were packaged in cartons
incorrectly labeled as 400 mg.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT All literature promoting Annedda Tablets (Pycongenol) as an
anti-aging nutritional supplement, in bottles containing 60
capsules. Recall #D-112-3.
CODE None.
MANUFACTURER Reseau International, Cincinnati, Ohio.
RECALLED BY Manufacturer, by letter dated December 31, 1992.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Canada, Bermuda.
QUANTITY 158 distributor kits were distributed.
REASON Marketed without new drug approval.
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PRODUCT Diphenhydramine Hydrochloride Capsules, USP 25 mg, in blue
tinted PVC blisters of 10 and 30 capsules per card, labeled as
a Rx drug for use as an antihistaminic and for motion sickness,
parkonsonism, nighttime sleep-aid. Recall #D-114-3.
CODE Package codes - 321071 and 321A71.
MANUFACTURER Purepac Pharmaceutical, Elizabeth, New Jersey.
RECALLED BY Medirex, Inc., Pine Brook, New Jersey (responsible firm), by
letters sent from August 27, 1992 to September 3, 1992.
Firm-initiated recall complete.
DISTRIBUTION Alabama, Illinois, Kentucky, New Jersey, Pennsylvania, South
Carolina, Virginia, Wisconsin, Connecticut, Indiana, Maryland,
North Carolina.
QUANTITY 1,909 cartons of 10 blister cards of 10 capsules (lot 321-071)
and 75 cartons of 20 blister cards of 30 capsules each (lot
321-A71) were distributed; firm estimates 1,903 cartons plus 29
capsules of lot 321-071 and 74 cartons plus 590 capsules of lot
321-A71 remain on the market.
REASON Expiration date should be January 93 instead of February 93.
PRODUCT Dilantin (Phenytoin Sodium) Extended Release Capsules, 100 mg,
blister pack, hospital unit doses (10 x 10 strips, a Rx drug
for use as an anti-seizure, anti-convulsant medication.
Recall #D-115-3.
CODE Lot #058DOFA.
MANUFACTURER Parke-Davis, Division of Warner-Lambert Company, Fajardo,
Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner-Lambert Company, Morris Plains,
New Jersey, by letter September 23, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 38,026 100-capsule units were distributed.
REASON Expiration date should be July 92 instead of July 93.
PRODUCT Benadryl Cold Tablets, in boxes containing 24 tablets.
Recall #D-116-3.
CODE Lot #00782V EXP 7/94.
MANUFACTURER Warner Lambert, Lititz, Pennsylvania.
RECALLED BY Manufacturer, by letter November 20, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION North Carolina, Connecticut.
QUANTITY Firm estimates 5 cases remain on the market.
REASON Product does not meet content uniformity specifications for
diphenhydramine ingredient.
PRODUCTS & Various drug products identified as follows.
CODES Recall #D-117/128-3.
Group A - 1. Cold & Allergy Tablets under the following labels:
Biolanta/Bioline, Fay's, Harvest, Mason Home Remedies,
Medi-Save, Reliable, Rite Aid, Rugby, Treasury and
Treasury-Silver Saver. All unexpired lots;
2. Antacid Plus Tablets, cherry flavored under the following
labels: Treasury and Treasury-Silver Saver. All unexpired lots;
3. Antacid Plus Tablets, lemon flavored under the following
labels: Good Health, Reliable, Treasury and Treasury-Silver
Saver. All unexpired lots;
4. Lite Coat Decongestant Tablets with Acetaminophen under the
following labels: Bonne Sante, Brooks, CVS, FDC, Good Health,
-3-
Good Neighbor Pharmacy, Hudson, MEDC, Navy Exchange, Pay n
Save, Reliable, Rite Aid, Schein, Shop n Save, Standard, The
Way It Was, Treasury, Treasury-Silver Saver, United
Supermarkets, Wellby Super Drug and Woolworth. All unexpired
lots;
5. Tri-Buffered Aspirin under the following labels:
Bills, Bradlees, Brooks, Caldo, Cardinal, CVS, Duane Reade,
Family Value, Fedco, Freddy's, Giant Eagle, Good Health,
Gramac, Grand Union, Hills, Hooks, Kinney Drug, Legend, Marsh,
Medic, Navy Exchange, Pay n Save, Perfect Match, Reliable,
Rexall, Roval, Shop n Save, Spencer, Standard, Stop n Shop,
Super Tru, Taylor, Thayer, The Way It Was, Treasury, Wegmens's,
Widmen, Winn Dixie, Woolworth, Treasury-Silver, United
Supermarket, Wellby Super Drug. All unexpired lots;
6. Enteric coated aspirin, 325 mg under the following labels:
Bills, Brooks, Cardinal, CVS, Family Value, Fay's, Freddy's,
Giant Eagle, Good Health, Hudson, K-Mart, Legend, Mason Home
Remedies, Meijer, Osco, Pay n Save, Pic n Save, Taylor,
Reliable, Rexall, Rite Aid, Royal, Schein, Shop n Save, Skaggs
Alpha Beta, Spencer, Standard, Thayer, Thrifty, Treasury,
United Supermarket, Wellby Super Drug. All unexpired lots
ending with letter C, D or E and the following lot numbers:
A6029F, AGO30F, A6031F, A6051F, A6052F and A6053F.
Group B - 1. Premenstrual Caplets under the following labels:
People's, Reliable and Shop n Save. Codes: J2074, J1122E,
C1439E;
2. Pink Bismuth Tablets under the following labels: Good
Health and Revco. Lot number for all labels is G1003E.
GROUP C - 1. Extra Strength Antacid Plus Liquid under the
following labels: Best Generics, Drug Guild, FDC, Kinney,
Legend, Rite Aid, Roval, Schein, Treasury and Williams
Generic. All unexpired lots;
Group D - 1. Acny 10% under the following labels: Epiderm,
Revco and Rexall. Lot code for all labels is D1218F.
Group E - 1. Extra Strength Cough Syrup under the following
labels: Hook, Our Family, Pathmark, Reliable, Rite-Aid, and
URL. Lot code for all labels is H1780D.
Group F - Cold/Allergy Elixir DM under the following labels
CVS, and Peoples. Lot code for both labels is C1570F.
MANUFACTURER Pennex Products Company, Inc., Verona, Pennsylvania.
RECALLED BY Manufacturer is using an independent firm to handle the
Recall. The firm, Fisher Steven, Fairlawn, New Jersey sent
recall packets December 7 and 21, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Group A - Potency not assured through Expiration date.
Group B - Product does not meet content uniformity
specifications.
Group C - Product does not meet viscosity specifications.
Group D - Incomplete in-process documentation.
Group E - Product subpotent for alcohol content.
Group F - Product superpotent for alcohol content.
-4-
PRODUCT NaFrinse, unit dose fluoride mouthrinse in 10 ml clear plastic
cups with peel off closures. Recall #D-129-3.
CODE Lot #15466 EXP 7/93.
MANUFACTURER Medical Products Laboratories, Inc., Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, on or about August 17, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Idaho.
QUANTITY 11 cases were distributed.
REASON Presence of Pseudomonas cepacia.
UPDATE Recall #D-108-3, Betatar Gel Shampoo, recalled by Beta
Dermaceuticals, which appeared in the February 3, 1993
Enforcement Report is cancelled since the firm did not conduct
a recall.
RECALLS AND FILED CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Red Blood Cells. Recall #B-138-3.
CODE Unit #5107451.
MANUFACTURER Department of the Navy, Naval Hospital Blood Bank, Beaufort,
South Carolina.
RECALLED BY Manufacturer, by telephone January 21, 1992. Firm-initiated
recall complete.
DISTRIBUTION New Jersey and Arizona.
QUANTITY 1 unit.
REASON Red Blood Cells, which tested repeatedly reactive for the
antibody to hepatitis B core antigen (anti-HBc), were
distributed.
PRODUCT Whole Blood. Recall #B-140-3.
CODE Unit #54-01226.
MANUFACTURER White Community Hospital, Aurora, Minnesota.
RECALLED BY Manufacturer, by telephone December 7, 1992. Firm-initiated
recall complete.
DISTRIBUTION Minnesota.
QUANTITY 1 unit.
REASON Blood product, which tested negative for the antibody to
hepatitis C virus encoded antigen (anti-HCV), but was collected
from a donor who previously tested repeatedly reactive for
anti-HCV, was distributed.
PRODUCT (a) Platelets, Expired; (b) Recovered Plasma.
Recall #B-141/142-3.
CODE Unit numbers: (a) 92-1773; (b) 91-3789, 91-3799, 91-3814,
91-3848, 91-3923, 91-4054, 91-4098, 91-4107, 91-4178,
91-4426, 92-0038, 92-0439, 92-0516, 92-0563, 92-0607,
92-0623, 92-0635, 92-0645, 92-0676, 92-0706, 92-0756,
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92-0797, 92-0801, 92-1038, 92-1049, 92-1059, 92-1153,
92-1156, 92-1221, 92-1228, 92-1245, 92-1250, 92-1270,
92-1271, 92-1290, 92-1301, 92-1484, 92-1544, 92-1565,
92-1650, 92-1744, 92-1773.
MANUFACTURER Merced County Blood Bank, Merced, California.
RECALLED BY Manufacturer, by letter August 28, 1992, followed by telephone
August 31, 1992. Firm-initiated recall complete.
DISTRIBUTION Delaware.
QUANTITY (a) 1 unit; (b) 42 units.
REASON Blood products were distributed for further manufacture into
non-injectable products which were: 1) untested; 2) collected
from donors who did not meet suitability requirements; 3)
collected from donors who demonstrated the signs or symptoms of
AIDS; 4) collected from donors who tested repeatedly reactive
for either the antibody to the hepatitis B core antigen
(anti-HBc) or the antibody to the hepatitis C virus encoded
antigen (anti-HCV) but were not labeled as such; 5) labeled
with an incorrect anticoagulant; 6) collected from autologous
donors who did not meet the suitability requirements for
allogeneic donors; 7) collected from a donor who tested
positive for syphilis by the rapid plasma reagin (RPR) test; or
8) labeled with an incorrect product name.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT (a) Platelets, Expired; (b) Recovered Plasma.
Recall #B-143/144-3.
CODE Unit numbers: (a) 91-3863, 91-4152, 91-4190, 91-4191, 91-4192,
91-4193, 91-4251, 92-0081, 92-0110, 92-0327, 92-0542, 92-0735,
92-0817, 92-0952, 92-1094, 92-1099, 92-1238, 92-1241, 92-1242,
92-1415;
(b) 91-3782, 91-3817, 91-3850, 91-3851, 91-3859, 91-3937,
91-3940, 91-4024, 91-4062, 91-4186, 91-4196, 91-4251, 91-4341,
91-4399, 92-0005, 92-0013, 92-0030, 92-0045, 92-0110, 92-0193,
92-0235, 92-0272, 92-0273, 92-0282, 92-0286, 92-0327, 92-0344,
92-0455, 92-0472, 92-0519, 92-0550, 92-0553, 92-0572, 92-0574,
92-0624, 92-0632, 92-0649, 92-0702, 92-0733, 92-0795, 92-0806,
92-0823, 92-0825, 92-0886, 92-0897, 92-0918, 92-0969, 92-0988,
92-1129, 92-1133, 91-1146, 92-1148, 92-1151, 92-1234, 92-1235,
92-1303, 92-1400, 92-1404, 92-1415, 92-1485, 92-1498, 92-1539,
92-1553, 92-1644, 92-1848, 92-1856.
MANUFACTURER Merced County Blood Bank, Merced, California.
RECALLED BY Manufacturer, by letter August 28, 1992, followed by telephone
August 31, 1992. Firm-initiated recall complete.
DISTRIBUTION Delaware.
QUANTITY (a) 20 units; (b) 66 units.
REASON Blood products were distributed for further manufacture into
non-injectable products which were: 1) untested; 2) collected
from donors who did not meet suitability requirements; 3)
collected from donors who demonstrated the signs or symptoms of
AIDS; 4) collected from donors who tested repeatedly reactive
for either the antibody to the hepatitis B core antigen
-6-
(anti-HBc) or the antibody to the hepatitis C virus encoded
antigen (anti-HCV) but were not labeled as such; 5) labeled
with an incorrect anticoagulant; 6) collected from autologous
donors who did not meet the suitability requirements for
allogeneic donors; 7) collected from a donor who tested
positive for syphilis by the rapid plasma reagin (RPR) test; or
8) labeled with an incorrect product name.
PRODUCT Whole Blood. Recall #B-139-3.
CODE Unit #41-02750.
MANUFACTURER Ely-Bloomenson Community Hospital, Ely, Minnesota.
RECALLED BY Manufacturer, by telephone November 19, 1992. Firm-initiated
recall complete.
DISTRIBUTION Minnesota.
QUANTITY 1 unit.
REASON Blood product, which tested reactive for syphilis by the Rapid
Plasma Reagin (RPR) assay, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT ColdSpor, sterilizing and disinfecting concentrate solution, in
1.6 ounce bottles, 6.4 ounce bottles and 25.6 ounce bottles,
for use on all medical devices, including ridid and flexible
endoscopes. Recall #Z-180-3.
CODE Product numbers MX5310, MX-5332, MX5316. All codes and sizes.
MANUFACTURER Metrex Research Corporation, Parker, Colorado.
RECALLED BY Manufacturer, by letter November 10, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Natonwide.
QUANTITY Approximately 2,000 cases per month were distributed.
REASON Product does not meet the guidance requirements for a "High
Level Disinfectant."
PRODUCT Bard PE Plus II Peripheral Balloon Dilation Catheter, used for
percutaneous transluminal angioplasty (PTA) of the femoral,
Iliac, and renal arteries, all sizes marketed by Bard prior to
June 1992. Recall #Z-248-3.
CODE Catalog numbers: 006400 through 006427.
MANUFACTURER C.R. Bard, Inc., Glens Falls, New York.
RECALLED BY C.R. Bard, Inc., Bard Radiology Division, Covington, Georgia,
by letter November 18, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 140,457 units were distributed; firm estimates less than 5%
remains on the market.
REASON Device was distributed without premarket approval authorization
for the labeled indication for use of the device in dilation of
the nephrostomy tract.
PRODUCT Adult Star Ventilators with Versions 216.0 through 217.2
Software. Recall #Z-252-3.
-7-
CODE Catalog No. Product No.
216 Version 9602160.1, 1203216, 1203216.1
217 Version 9602170,0, 9602170.1, 1203217.0, 1203217.1,
1203217.2
MANUFACTURER Infrasonics, Inc., San Diego, California.
RECALLED BY Manufacturer, by letter December 11, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 430 units were distributed.
REASON Under certain circumstances the ventilator may prematurely
terminate breaths, resulting in insufficient ventilation of the
patient, due to software malfunction at certain settings.
PRODUCT Opti-Plast 5F PTA Angioplasty Balloon Catheters, sterile,
non-pyrogenic Rx devices recommended for use in Percutaneous
Transluminal Angioplasty of the peripheral vascular system.
Recall #Z-254-3.
CODE Catalog #PAC-10551, lot #324-700A.
MANUFACTURER Vas-Cath, Inc., Mississauga, Ontario, Canada.
RECALLED BY Manufacturer, by telephone October 27 and 30, 1992, and Faxed
letters December 3, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Utah, Michigan, Indiana, New Jersey, Kansas, Alabama.
QUANTITY 66 pouches were distributed; firm estimates 8 pouches remain on
the market.
REASON 8 mm x 3 cm 5F Opti-Plast Balloon Catheter pouches were found
to contain 6 mm x 4 cm 5F Catheters.
PRODUCT Soft-Cell Permanent Dual Lumen Catheters, sterile,
non-pyrogenic, Rx devices recommended for use in attaining
short term or prolonged vascular access for hemodialysis,
hemoperfusion, or apheresis therapy via the jugular or
subclavial vein. Recall #Z-255-3.
CODE Catalog #PDLT-5523 PC, Lot #245-531.
MANUFACTURER Vas-Cath, Inc., Mississauga, Ontario, Canada.
RECALLED BY Manufacturer, by telephone December 3-4, 1992, and faxed
letters on December 4, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Indiana, Washington state, California.
QUANTITY 40 pouches were distributed; firm estimates none remains on the
market.
REASON 7.5 inch tip Soft-Cell Catheters (PDLT-5519 PC) were packaged
in pouches labeled as containing 9 inch tip Soft-Cell Catheters
(PDLT-5523 PC).
PRODUCT CATH-SEAL, percutaneous catheter introducers (PCI) with 3-way
stopcock:
(a) 10, 11, 12 and 14F size; sheath teflon. Large balloon
catheter introducer set with white teflon sheath and a molded
fitting polyethylene dilator. Catalog numbers 1200-90-3030 AND
1200-90-3040, 10FR; 1200-90-3011, 11FR; 1200-90-3022, 12FR;
1200-90-3003, 14FR; 1200-90-3041, 11FR. A PCI and dilator
-8-
packaged per pouch. 5 pouches per box. Each pouch and box
labeled the same, except for catalog number and size.
(b) 10, 11, and 12F sizes; sheath teflon. Large balloon
catheter introducer set with luer lock fitting on white teflon
sheath hub and a molded fitting polyethylene dilator. Catalog
numbers 1205-60-3700, 10FR; 1205-60-3701, 11FR; 1205-60-3702,
12FR. A PCI, dilator and guidewire packaged per tray. 5 trays
per box. Each tray and box labeled the same, except for catalog
number and size.
(c) 10 and 11F size; sheath teflon. Large balloon catheter
introducer set with white teflon sheath and a molded fitting
polyethylene dilator. Catalog Number 1200-90-2630, 10FR
packaged in a pouch. Each pouch contains one PCI, dilator and
guidewire. 3 pouches per box. Each pouch and box labeled the
same.
CATH-SEAL Percutaneous Catheter introducers sold in bulk,
non-sterile:
(d) With side arm: Catalog numbers 0001-10-1623, 0001-10-1653,
0001-10-1654, 0001-10-1664, 0001-10-1671, 0001-10-1676,
0001-10-1677 are packaged either 60 or 120 per box. Each
package is labeled the same, except for catalog number and
quantity. Catalog numbers 0001-10-1623, 0001-10-1653,
0001-10-1676 are packaged 120/box. Catalog numbers
0001-10-1654, 0001-10-1671, and 0001-10-1677 are packaged
60/box;
(e) Without Sidearm: Catalog number 0001-10-1675, 10F, package
120 units per box. The bulk, non-sterile products are sold to
OEM kit manufacturers who use them in various kits. The only
products affected in this case were kits assembled by Boston
Scientific. Recall #Z-256/260-3.
CODE Catalog No. Lot No.
1200-90-2630 137258
1200-90-3003 137240, 137887, 138000, 138034, 138088, 138216,
138392
1200-90-3011 137259, 137373, 137698, 137802, 137803, 137841,
138062, 138215, 138220, 138255
1200-90-3022 137074, 137260, 137801, 138036
1200-90-3030 136821, 137211, 137241, 137249, 137250, 137251,
137262, 137263, 137264, 137265, 137266, 137308,
137309, 137310, 137311, 137566, 137601, 137602,
137603, 137819, 137825, 138035, 138124
1200-90-3040 138158
1200-90-3041 138367
1205-60-3700 137091, 137205, 137267, 137768, 137834, 137842,
137843, 137856, 137900, 137994, 137999, 138024,
138221, 138257 138347, 138433, 138436
1205-60-3701 136333, 136829, 137207, 137209, 137775, 137843,
138033, 138222, 138393
1205-60-3702 137776, 138032, 138400, 138435
0001-10-1623 137146, 137660
0001-10-1653 136539, 136540, 136541
0001-10-1654 137488, 137840
0001-10-1664 137606
-9-
0001-10-1671 137422, 138040
0001-10-1675 138040, 138060
0001-10-1676 138187
0001-10-1677 138188, 138189
MANUFACTURER Universal Medical Instruments, Ballston Spa, New York.
RECALLED BY Manufacturer, by telephone beginning December 9, 1992 and by
letters dated December 9-21, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Italy, Holland, Australia, Sweden, Spain, Canada,
Israel.
QUANTITY Volume of product in commerce:
1200-90-2630 - 110 pieces
1200-90-3003 - 237 pieces
1200-90-3011 - 1515 pieces
1200-90-3022 - 457 pieces
1200-90-3030 - 1389 pieces
1200-90-3040 - 5 pieces
1200-90-3041 - 5 pieces
1205-60-3700 - 2108 pieces
1205-60-3701 - 863 pieces
1205-60-3702 - 152 pieces
001-10-1623 - 781 pieces
0001-10-1653 - 1504 pieces
0001-10-1654 - 759 pieces
0001-10-1664 - 486 pieces
0001-10-1671 - 598 pieces
0001-10-1675 - 967 pieces
0001-10-1676 - 1000 pieces
0001-10-1677 - 515 pieces
REASON The bond between the sheath and hub assembly may be compromised
after the unit is submerged for greater than 2 hours in some
solutions.
PRODUCT V. Mueller 3 mm Leather Valve Cutter, Catalog #CH8686, a
sterile, single-use component of the Baxter V. Mueller Leather
In Situ Valve Cutter Kit, Catalog #CH8685, for use in the
serial valve incision method in situ saphenous vein arterial
bypass procedures. Recall #Z-264-3.
CODE Lot numbers: 1902514, 1910380, 1910724, 1911462, 1921859.
MANUFACTURER Techno Synthetic, Switzerland.
RECALLED BY Baxter Healthcare Corporation, Niles, Illinois, by letter
September 14, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 2,156 cutters were distributed.
REASON The screw thread on the end of the cutters were not
manufactured properly, not allowing the cutter to attach
properly to the catheter.
MEDICAL DEVICE SAFETY ALERTS:
PRODUCT Uncuffed Hi-Lo Jet Tracheal Tube, all sizes, used in the
delivery of jet ventilation for the management of
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bronchopleural air leaks:
(a) 2.5 mm I.D. - Cat. No. 86622
(b) 3.0 mm I.D. - Cat. No. 86623
(c) 3.5 mm I.D. - Cat. No. 86624
(d) 4.0 mm I.D. - Cat. No. 86625
(e) 4.5 mm I.D. - Cat. No. 86626
(f) 5.0 mm I.D. - Cat. No. 86627
(g) 5.5 mm I.D. - Cat. No. 86628
(h) 6.0 mm I.D. - Cat. No. 86629. Safety Alert #N-014/021-3.
(Note: "M" changed to "N" number).
CODE All lot numbers.
MANUFACTURER Mallinckrodt Anesthesia Products, Argyle, New York.
ALERTED BY Manufacturer, by letter January 8, 1993.
DISTRIBUTION Nationwide, Canada, Ireland, Mexico.
QUANTITY Firm estimates less than 5,000 units remain on the market.
REASON Difficulty passing tube's lumen when using a 6 FR or larger
suction catheter. Passage of a suction catheter can encounter
resistance due to the extremely small lumen of the tracheal
tube.
MASS SEIZURE:
PRODUCT Cocoa beans (93-586-076).
CHARGE; Adulterated - The articles have been held under insanitary
conditions whereby they may have become contaminated with
filth.
FIRM Lambert's Point Docks, Norfolk, Virginia.
FILED January 27, 1993; U.S. District Court for the Eastern District
of Virginia; Civil #2:93CV63, FDC #66663.
SEIZED January 28, 1993 - goods valued at approximately $15,000,000.
SEIZURE:
PRODUCT Various in vitro diagnostic test kits and components
(93-698-090/096).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, packing, and
storage are not in conformity with current good manufacturing
practice regulations. Misbranded - the articles' labeling
fails to bear adequate directions for use for the purposes for
which they are intended.
FIRM Immuno Diagnostic Products, Inc., North Salt Lake, Utah.
FILED January 19, 1993; U.S. District Court for the District of
Utah, Central Division; Civil #93-C-053W, FDC #66660.
SEIZED January 21, 1993 - goods valued at approximately $15,000.
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END OF ENFORCEMENT REPORT FOR FEBRUARY 10, 1993. BLANK PAGES MAY
FOLLOW.