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
08/19/1992
RECALLS AND FIELD CORRECTIONS: August 19, 1992
FOODS -- CLASS I
92-34
PRODUCT Frozen Crabmeat, in 8 ounce tubs, unlabeled or under Young's
Shellfish label. Recall #F-486-2.
CODE C372.
MANUFACTURER Young's Shellfish Company, Inc., Belfast, Maine.
RECALLED BY Manufacturer, by telephone July 1, 1992, followed by letter on
or about July 7, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Vermont.
QUANTITY 150 pounds were distributed.
REASON Product is contaminated with Listeria monocytogenes.
PRODUCT Fresh Backfin Crabmeat. Recall #F-487-2.
CODE None.
MANUFACTURER Edwards Seafood, Onley, Virginia.
RECALLED BY Manufacturer, by telephone June 15, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Washington, D.C.
QUANTITY 100 pounds were distributed; firm estimates none remains on the
market.
REASON There is a potential for contamination with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Carousel brand Rich and Creamy Cheese Cake, packed in 4 ounce
metal cups with plastic sealed tops. Recall #F-224-2.
CODE All codes.
MANUFACTURER Carousel Foods, Inc., Glenville, New York.
RECALLED BY Manufacturer, by letter February 18, 1992. Firm-initiated
recall complete.
DISTRIBUTION New York, New Jersey, Pennsylvania.
QUANTITY 500 cases (24 cups per case) were distributed.
REASON There is a remote potential for contamination with Clostridium
botulinum.
PRODUCT (a) Winters Pure Sugar Cane Syrup, in 25 and 12 fluid ounce
glass bottles; (b) Winters Pure Cane Syrup, in 25 and 12 fluid
ounce bottles. Recall #F-466/467-2.
CODE All product manufactured between 1/13/92 and March 31, 1992.
Product in 25 fluid ounce and 12 fluid ounce bottles did not
bear lot numbers or serial numbers.
MANUFACTURER Winters & Son, Inc., West Green, Georgia.
RECALLED BY Manufacturer, by letter July 25, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Georgia, Florida.
QUANTITY 300 cases (12 25-ounce bottles per case) and 15 cases (12
12-ounce bottles per case) were distributed.
REASON Product contains undeclared corn syrup.
PRODUCT Pasteurized Caviar in blue tins, 3-1/6 ounces. Recall #F-468-2.
CODE All product.
MANUFACTURER Royal Baltic Ltd., Brooklyn, New York.
RECALLED BY Manufacturer, by telephone and by letters dated June 5, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION New York, Massachusetts.
QUANTITY 79 tins were distributed.
REASON Product contains the unsafe food additive, borates.
PRODUCT Canned Mushrooms, in 68 ounce cans, grown in the People's
Republic of China and packed in Hong Kong. Recall #F-469-2.
CODE MPS-TC-1Y28.
MANUFACTURER Tak Chance Food Products, Ind., Ltd., Tseun Wan, Hong Kong.
RECALLED BY Tak Yuen Corporation, San Leandro, California, by letter May
14, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Washington state, Oregon, Idaho, California, Nevada, Texas,
Colorado, Minnesota, Missouri, Michigan, Wisconsin, Florida.
QUANTITY 444 cases were distributed.
REASON Product is contaminated with Staphylococcal Enterotoxin.
-2-
PRODUCT Various Fruit Pastry Fillings: Bono Apple Danish, Viking Apple
Danish, and Fettings Frozen Products Apple Danish. The three
products have the same formulation and are fruit filling or
topping products for Danish Sweet Rolls, packaged in 2 pound
flexible plastic tubs. Recall #F-471-2.
CODE All lots made prior to Julian date 154 of 1992.
MANUFACTURER Best Brands, Inc., Eagen, Minnesota.
RECALLED BY Manufacturer, by telephone July 21, 1992, followed by letter
July 22, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Missouri, North Dakota, Minnesota.
QUANTITY Firm estimates 100 24-pound cases remain on the market.
REASON Product contains undeclared sulfites.
PRODUCT Rival Variety and Perfection Variety Fresh Apricots, in 17
pound and 24 pound containers. Recall #F-472-2.
CODE MSCRO followed by 6/23U92, 6/25H92, 6/27Q92, 7/1092, 6/25G92,
6/27092, 6/27R92.
MANUFACTURER Johnny Appleseed Company of Washington/CRO Fruit Company,
Wenatchee, Washington.
RECALLED BY Manufacturer, by telephone July 9, 1992, followed by letter
July 10, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, New York, Michigan, California, Connecticut,
Washington state.
QUANTITY 407 17-pound boxes and 109 24-pound boxes were distributed.
REASON Product is contaminated with pesticides, acephate and
methamdidophos.
PRODUCT Pan Dulce (sweet bread), Mexican fresh pastry products, 10
ounces: (a) Mantecadas; (b) Cochinitos; (c) Empanadas; (d)
Galleta de Azucar; (e) Semitas de Amoz;
(f) Pan de Huevo; (g) Pan Fino. Recall #F-473/479-2.
CODE All lots manufactured prior to April 30, 1992.
MANUFACTURER C Ramirez & Sons Food Manufacturing, Inc., Hereford, Texas.
RECALLED BY Manufacturer, by letter April 30, 1992. Firm-initiated recall
complete.
DISTRIBUTION Oklahoma, Texas.
QUANTITY Firm estimates none remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTION: FOODS -- CLASS III
PRODUCT Flavorzest Oral Liquid, in 16 ounce plastic bottles, a
multi-vitamin for children. Recall #F-463-2.
CODE Lot #051920 EXP 4/95.
MANUFACTURER Vita-Fore Products Company, Inc., Ozone Park, New York.
RECALLED BY Manufacturer, by telephone and letter July 17, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION New York.
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QUANTITY 6 cases x 74 bottles were distributed.
REASON Product is incorrectly labeled as to quantity of concentrate.
PRODUCT Fresh Gutted Mahi-Mahi Fish imported from Ecuador. Recall
#F-465-2.
CODE Uncoded.
MANUFACTURER Independent Seafoods, West Palm Beach, Florida.
RECALLED BY Manufacturer, by telephone June 13, 1992. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 600 pounds were distributed.
REASON Product is decomposed.
PRODUCT Minute Maid Orange Juice, in 8.45 fluid ounce tetra brik
packages. Recall #F-470-2.
CODE DEC1392AB.
MANUFACTURER Coca-Cola Foods, Anaheim, California.
RECALLED BY Coca-Cola Foods, Houston, Texas, by visit July 8, 1992.
Firm-initiated recall complete.
DISTRIBUTION California, Oregon.
QUANTITY 480 cases (27 packages per case) were distributed; firm
estimates none remains on the market.
REASON Product contained in swollen containers.
PRODUCT Various salad dressing:
(a) Ken's Steak House Lite Caesar Dressing, in 8 ounce bottles;
(b) Ken's Steak House Olive Oil Vinaigrette Dressing, in 8 and
16 ounce bottles. Recall #F-480/481-2.
CODE (a) All bottles with expiration date of 16 FEB 93;
(b) All bottles with expiration date of 2 MAR 93 and 7 MAR 93.
MANUFACTURER Ken's Foods, Inc., Marlborough, Massachusetts.
RECALLED BY Manufacturer, by telephone June 30, 1992, followed by letter
July 1, 1992. Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Pennsylvania, Massachusetts, Maine.
QUANTITY (a) 10,696 cases (12 bottles) per case; (b) 2,120 cases (12
8-ounce bottles per case), and 851 cases (6 16-ounce bottles
per case) were distributed.
REASON Product is contaminated with yeast.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
PRODUCT Albuterol Sulfate, bulk powder, a bulk chemical repackaged into
4 sizes of bottles, 10 gms, 25 gms, 100 gms, 500 gms, for use
in compounding prescription bronchodilator medications.
Recall #D-450-2.
-4-
CODE PCCA Lot 13401.
MANUFACTURER Topchem s.r.l., Milano, Italy.
RECALLED BY Professional Compounding Centers of America, Inc., Houston,
Texas, by letter September 6, 1991. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 8,945 grams were distributed; firm estimates none remains on
the market.
REASON Product labeled Albuterol Sulfate identified by analysis as
Dextromethorphan hydrobromide.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Acetaminophen Elixir, 80 mg acetaminophen per 1/2 teaspoon, an
OTC oral liquid, under the following labels: Esquire,
Mediguard. Recall #D-451-2.
CODE Lot numbers: 10088, 11006, 11011, 11015, 11026, 11031, 11041,
11046, 11052, 11067.
MANUFACTURER Esquire Pharmaceuticals, Inc., Westmont, Illinois.
RECALLED BY Manufacturer, by letter June 10, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 48,928 4-ounce bottles and 10,704 8-ounce bottles were
distributed; firm estimates that little remains on the market.
REASON Markings on dosage cups not totally compatible with labeled
dosage instructions.
RECALLS AND FIELD CORRECTION: DRUGS -- CLASS III
PRODUCT Sunrise Smooth Metamucil, orange flavored psyllium fiber, in
.43 ounce packets, an OTC oral soluble fiber. Recall #D-452-2.
CODE Lot number 2149XD061 EXP 3/94.
MANUFACTURER Procter & Gamble Company, Phoenix, Arizona.
RECALLED BY Procter & Gamble Company, Cincinnati, Ohio, by telephone
between July 20 and 24, 1992, followed by letter on or about
July 21, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 620 cases were distributed. There are 30 packets to a shelf
carton and 12 shelf cartons to case.
REASON Some individual packets are mislabeled as "Sugar-Free." The
cartons are correctly labeled as the sugar containing product.
PRODUCT Hydrocodone Bitartrate and Acetaminophen Tablets, 5 mg/500 mg
each, in 500 tablet bottles, a Rx analgesic, under the Goldline
and Halsey Drug labels. Recall #D-453-2.
CODE Lot #1G08D.
-5-
MANUFACTURER Halsey Drug Company, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by letter July 9, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Florida.
QUANTITY 1,986 bottles were distributed.
REASON Presence of mold.
PRODUCT Precaine Topical Anesthetic in both aerosol and gel forms, a Rx
dental drug. Recall #D-454/455-2.
CODE All lot numbers.
MANUFACTURER Pascal Company, Inc., Bellevue, Washington.
RECALLED BY Manufacturer, by letter June 15, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,844 units of gel and 2,015 units of aerosol were distributed;
firm estimates 1,200 units remain on the market.
REASON Products marketed without new drug approval.
PRODUCT Ibuprofen Tablets, 400 mg, in 120 tablet bottles, an OTC
analgesic. Recall #D-456-2.
CODE Lot numbers: 06617 EXP 7/93, 06618 EXP 7/93.
MANUFACTURER Boots Pharmaceuticals, Inc., Shreveport, Louisiana.
RECALLED BY Manufacturer, by letter. Firm-initiated recall ongoing.
DISTRIBUTION Illinois, California, New Jersey.
QUANTITY 11,550 bottles were distributed.
REASON Product does not meet dissolution specifications.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
PRODUCT Spacelabs Model 90510 (First Medic 510) Defibrillator.
Recall #Z-959-2.
CODE All serial numbers from 0001 through 0308.
MANUFACTURER Spacelabs, Inc., Hillsboro, Oregon.
RECALLED BY Spacelabs, Inc., Redmond, Washington, by letter June 23, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, UK, Germany.
QUANTITY 274 units were distributed.
REASON The defibrillator may not function due to cable kinks resulting
in cable connectors becoming dislodged after continued opening
and closing of the lid on the top of the defibrillator which
contains the operator display.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Surgical Instruments Imported from Pakistan:
1. Iris Scissors, Straight;
-6-
2. Forester Sponge Holding Forceps;
3. Mosquito Forceps 5" Curved;
4. Adson Dressing Forceps;
5. Adson Tissue Forceps;
6. Webster N. Holders;
7. Kelly Forceps Curved;
8. Disposable Towell Forceps;
9. Mosquito Forceps 3 1/2" Curved;
10. Baumgartner Needle Holders;
11. Backhaus Towel Forceps;
12. Lister Bandage Scissors;
13. Articulating Paper Forceps;
14. Rankin Crile Forceps Straight;
15. Mayo Hegar Needle Holders;
16. Bob Parker Handle;
17. Baby Allis Tissue Forceps;
18. Kelly Scissors;
19. Roger Wire Cutting Scissors, Angular;
20. Webster Needle Holders Satin;
21. Eye Dressing Forceps 1/2" Curved;
22. Evacuation Forceps, 14mm Width;
23. Plaster Nippers;
24. Roger Wire Scissors;
25. Evacuation Forceps, 15mm Width;
26. Schamber Comedone Extractors;
27. Doyen Intestinal Clamp Curved;
28. Doyen Intestinal Clamp Straight;
29. Mosquito Forceps 5" Straight;
30. Evacuation Forceps, 19mm Width;
31. Sophar CVUM Forceps;
32. Rankin Crile;
33. Sims Uterine Sounds;
34. Micro Alligator Forceps, Cupped Typed;
35. Iris Scissors Straight McCoys;
36. Lister Bandage Scissors McCoys;
37. Fine Point Forceps, with Guide Pin;
38. Operating Scissors, Smooth Blunt;
39. Operating Scissors, Smooth Smooth, 5 1/2" Straight McCoys;
40. Operating Scissors, Smooth Smooth, 4 1/2" Straight;
41. Light Mall Probes;
42. Screw Lock Scalpel Handles;
43. Vienna Nasal Speculums Medium;
44. Rochester Pean;
45. Mayo Hegar Needle Holders 8";
46. Lister Bandage Scissors 4 1/2";
47. Allis Tissue Forceps;
48. Thumb Dressing Forceps;
49. Tooth Extracting Forceps, Number 16-S;
50. Tooth Extracting Forceps, Number 150-S;
51. Tooth Extracting Forceps, Number 151-S;
52. Bozeman Uterine Dressing Forceps Curved;
53. Bozeman Uterine Dressing Forceps Straight;
54. Tooth Extracting Forceps No:Mayo Scissors;
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55. Eye Dressing Forceps 1/2" Curved 4";
56. Rochester Pean Forceps 12" Curved;
57. Rochester Pean Forceps 12" Straight;
58. Plain Splinter Forceps;
59. Cartilage Splinter Forceps;
60. College Dental Tweezers;
61. Rochester Pean Forceps 8" Curved;
62. Sponge Holding Forceps, Smooth Jaws;
63. Doyen Intestinal Clamps 9 1/2" Straight;
66. Webster Needle Holders 5" Standard;
67. Weitlaner Retractors;
68. Webster Needle Holders 5" Fine Point;
69. Mosquito Clamps 5" Curved;
70. Gum Scissors Straight;
71. Kelly Clamps Curved;
72. Dissecting Scissors, Smooth Blunt;
73. Mayo Dissection Scissors Straight;
74. Lister Bandage Scissors 5 1/2" Straight;
75. Bandage Scissors;
76. Dissection Forceps;
77. Gum Scissors Curved;
78. Dissection Forceps 4 3/4";
79. College Tweezers;
80. U.S. Army Gauze 8" Scissors;
81. Kelly Clamp Straight;
82. Roaching Shears;
83. Holzheimer Skin Retractors;
84. Rankin Crile Forceps Curved;
85. Babinski Percussion Hammers Large;
86. Babinski Percussion Hammers, Large 10";
87. Schroeder Tenaculum Forceps;
89. Magille Catheter Forceps Adult Size;
90. Bandage Scissors with one Heavy Blade;
91. U.S. Army Gauze Scissors 8 1/2";
92. Graves Speculums Small;
93. Cusco Speculums Medium;
94. Crown Scissors Smooth Blades;
95. Mayo Hegar Needle Holders 6" in Bag;
96. Webster Needle Holders 5" in Bag;
97. Sponge Stick 7" Straight;
98. Suture Scissors;
99. Dissection Forceps in Bag;
100. Kelly Scissors 6 1/4" Straight 1 Blade;
101. Mayo Hegar Needles Holders 5";
102. Plain Splinter Forceps 3 1/2";
103. Mosquito Clamps 5" Straight;
104. College Pliers;
105. Providence Hospital Clamps;
106. Dissecting Forceps 5 1/2";
107. Rochester Pean Forceps 7 1/4 Curved;
108. Doyen Clamps;
109. Babcock Forceps;
110. Magille Catheter Forceps Child Size;
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111. Lister Bandage Scissors 7 1/4";
112. Student Dissecting Forceps 1/2" Curved & Full Curved;
113. Hartmann Forceps;
114. Rochester Pean Forceps 8" Curved;
115. Student Dissecting Forceps Full Curved;
116. Cartilage Forceps Curved;
117. Rochester Pean Forceps 8" Straight;
118. Crown Scissors Smooth Blades Straight;
119. Crown Scissors Smooth Blades Curved;
120. Student Dissecting Forceps Serrated 1/2" Curved;
121. Ringes Expander Pliers,
122. McCoys Fine Point Forceps No. 3160;
123. McCoys Dissection Scissors Smooth Smooth Straight No. 1155;
124. Student Dissecting Scissors No. 5520;
125. McCoys Dissection Scissors Smooth Blunt;
126. Dissection Scissors Smooth Smooth Straight No. 1150;
127. McCoys Dissection Scissors Smooth Smooth No. 1150;
128. Dissection Scissors, Smooth Blunt Straight;
129. Dissecting Forceps 6" McCoys;
130. Towel Clamps;
131. Tooth Extracting Forceps No. 150;
132. Tooth Extracting Forceps No. 69;
133. Rochester Pean Curved Forceps 7 1/4";
134. Dissecting Forceps 5 1/2";
135. Darryan;
136. Mosquito Clamps 3 1/2" Straight in Bag;
137. Jansen Gruenwald Nasal Forceps;
138. Rochester Pean Forceps Curved (Special);
139. Metzenmbaum Scissors Curved;
140. Poultary Scissors;
141. Kelly Scissors 6 1/4" Straight;
142. Metzenmbaum Scissors Curved;
143. Iris Scissors 4 1/2" Straight Regular in Bags;
144. Lister Bandage Scissors in Boxes;
145. Operating Scissors Smooth Blunt;
146. Kelly Forceps 5 1/2" Straight;
147. Towel Clamps 3 1/2" in Bags;
148. U.S. Army Scissors 8";
149. Bozeman Uterine Forceps 10 1/2";
150. Gum Scissors Straight No. 1167;
151. Mosquito Clamps 3 1/2" Straight in Bags;
152. Kelly Scissors 6 1/4" Curved 1 Blade.
Recall #Z-1004/1152-2.
CODE AWB numbers (airway numbers): 214 5376 3812LHE NYC 3818/157 and
214 5378 8210/298LHE NYC.
MANUFACTURER Tinopal Surgical, PVT, LTD, Sialkot-4, Pakistan.
RECALLED BY Fine Surgical Instruments Corporation, Hempstead, New York, by
letter on or about May 12, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 512,589 pieces were distributed
REASON The devices were imported from Pakistan and/or are labeled as
stainless steel, and are subject to refusal of admission under
Import Alert #76-01. The devices were subsequently distributed
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into interstate commerce. The quality of the device fails to
meet established standard requirements for the appropriate type
of stainless steel, as entered, labeled or promoted. The
devices also lack an approved 510(k).
PRODUCT Brockenbrough Fittings (stopcocks), Item #002414, used with
USCI 8.5F Brockenbrough Transseptal Catheters.
Recall #Z-1161-2.
CODE Lot numbers: 07EA3983, 07AB2197, 07GB3882, 07HA1936, 07DB0795,
07LA7505, 07DB3818.
MANUFACTURER Bard Urological Division of C.R. Bard, Inc., Glens Falls, New
York.
RECALLED BY USCI Division of C.R. Bard, Inc., Billerica, Massachusetts, by
letter and by telephone February 25, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Ireland.
QUANTITY 330 units were distributed.
REASON The stopcocks were modified without a male fitting, causing a
potential for a non-reliable fit between the stopcocks and the
catheters, which could result in leakage and/or introduction of
air into the system.
PRODUCT LDS 1700 Series Adult Heated Anesthesia Circuits, non-sterile,
single patient use, Rx devices for use with LDS brand
humidifiers intended to be used for respiratory care,
anesthesia, or situations where upper respiratory tract is
bypassed or heated and humidified gas are delivered to the
patient:
1. LDS-17340 and LDS-17340E Single Limb, 40";
2. LDS-17360 and LDS-17360E Single Limb, 60";
3. LDS-17372 and LDS-17372E Single Limb, 72";
4. LDS-17440 and LDS-17440E Circle, Dual Wire, 40";
5. LDS-17441 and LDS-17441E Circle, Dual Wire, 40", 40"
Extension Filter Flex II;
6. LDS-17450 and LDS-17450E Circle, Dual Wire, 40";
7. LDS-17460 and LDS-17460E Circle, Dual Wire, 60";
8. LDS-17470 and LDS-17470E Circle, Single Wire, 60";
9. LDS-17480 and LDS-17480E Circle, Dual Wire, 80";
10. LDS-17490 and LDS-17490E Circle, Single Wire, 72";
11. LDS-17499-108 and LDS-17499-108 Ventilator, Single
Wire, 72";
12. LDS-17630 and LDS-17630E Ventilator, Dual Wire, 60";
13. LDS-17640 and LDS-17640E Ventilator, Single Wire, 60";
14. LDS-17641 and LDS-17640E Ventilator, Single Wire,
60" with 10" Nebulizer;
15. LDS-17642 and LDS-17642E Ventilator, Single Wire,
60" with 20" Nebulizer;
16. LDS-17648-271 and LDS-17648-271E Ventilator, Single
Wire, 60" with Low Flow Cannister, Filter Flex II;
-10-
17. LDS-17651 and LDS-17651E Ventilator, Single Wire,
60" with 10" Water Trap;
18. LDS-17652 and LDS-17652E Ventilator, Single Wire,
60" with 20" Water Trap;
19. LDS-17660 and LDS-17660E Ventilator, Dual Wire, 60";
20. LDS-17661 and LDS-17661E Ventilator, Dual Wire, 60"
with 10" Nebulizer;
21. LDS-17730 and LDS-17730E Ventilator, Dual Wire, 72"
with 20" Water Trap;
22. LDS-17740 and LDS-17740E Ventilator, Single Wire, 72";
23. LDS-17741 and LDS-17741E Ventilator, Single Wire,
72" with 10" Nebulizer;
24. LDS-17742 and LDS-17742E Ventilator, Single Wire,
72" with 20" Nebulizer;
25. LDS-17748-271 and LDS-17748-271E Ventilator, Single
Wire, 72" with Low Flow Cannister, Filter Flex II;
26. LDS-17751 and LDS-17751E Ventilator, Single Wire,
72" with 10" Water Trap;
27. LDS-17752 and LDS-17752E Ventilator, Single Wire,
72" with 20" Water Trap;
28. LDS-17760 and LDS-17760E Ventilator, Dual Wire, 72";
29. LDS-17761 and LDS-17761E Ventilator, Dual Wire, 72";
30. LDS-17764 and LDS-17764E Ventilator, Dual Wire, 72"
with 2 Port Wye. Recall #Z-1162/1191-2.
CODE Lot numbers: 136001 through 208000.
MANUFACTURER Life Design Systems, a division of Bird Medical Technologies,
Inc., Carrollton, Texas.
RECALLED BY Manufacturer, by letter May 11, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 1,722 units were distributed; firm estimates none remains on
the market.
REASON Device may have loose crimps on the terminals of the circuit
wires which may cause the circuit not to heat.
REASON Device may cause an artifact and the release of excessive
ultrasound (Isppa) and mechanical index.
PRODUCT Mainstream CO2 Airway Adapter, a single-use adapter for use
with MGA-IR Mainstream C02 Modules, used to measure carbon
dioxide concentration in respiratory gases. Recall #Z-1195-2.
CODE Catalog #405908-001, lot numbers 9213 and 9221.
MANUFACTURER Pryon Corporation, Menomonee Falls, Wisconsin.
RECALLED BY Marquette Electronics, Inc., Milwaukee, Wisconsin, by letter
June 22, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,490 units of lot 9213 and 1,510 units of lot 9221 were
distributed.
REASON Some of the adapters may have molding flash, which is visible
as pieces of plastic threads that are not completely removed
during the molding process.
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PRODUCT Reichert Jung Unistat Bilirubinometer, a stat photometric
analyzer for determining total bilirubin concentration in
neonates up to 7 days old. Recall Z-1197-2.
CODE Model 10310 (110 volt), and Model 10311 (220 volts). All
serial numbers.
MANUFACTURER Leica, Inc., Buffalo, New York.
RECALLED BY Manufacturer, by letter March 4, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 193 units of model 10310 and 222 units of model 10311 were
manufactured.
REASON The device may display a falsely low value when reading samples
with elevated bilirubin levels.
PRODUCT Prestilix 1690 and 1690S X-ray Tables. Recall #Z-1198-2.
CODE Model Z.7A9A5.902B.
MANUFACTURER General Electric Medical Systems, Milwaukee, Wisconsin.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
July 22, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 45 units were distributed.
REASON Noncompliance with the Performance Standards for Radiographic
Equipment in that it failed to meet the x-ray field alignment
requirements for spot-file devices, in that torsional twist of
support arm allows diagnostic source assembly to sag, causing
misalignment of the x-ray field.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT Neovet Neomycin Sulfate for Oral or topical use, 200 mg/ml, in
1 gallon plastic bottles, OTC for the treatment of diarrhea and
bacterial enteritis in cattle, swine, sheep, horses, and
poultry when the illness is due to organisms susceptible to
neomycin. Recall #V-046-2.
CODE Lot #B121 EXP 10/92.
MANUFACTURER Sparhawk Laboratories, Inc., Kansas City, Kansas.
RECALLED BY Manufacturer, by letter June 4, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Missouri.
QUANTITY 996 1-gallon bottles were distributed.
REASON Product is contaminated with mold.
PRODUCT Lactated Ringer's Injection, USP, in 1000 ml plastic bottles,
Rx, intravenous or subcutaneous administration, for replacement
of acute fluid and electrolyte losses and for correcting mild
acidosis. Recall #V-047-2.
CODE Lot #50330.
MANUFACTURER Sanofi Animal Health, Inc., Fort Dodge, Iowa.
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RECALLED BY Sanofi Animla Health, Inc., Overland Park, Kansas, by letter
July 20, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Maryland, Oklahoma, Colorado, Illinois, Texas, Iowa, South
Dakota, Nebraska, Massachusetts, Louisiana.
QUANTITY 6,178 bottles were distributed.
REASON Lack of sterility.
MEDICAL DEVICE SAFETY ALERTS:
PRODUCT Humidifier probes with dual temperature sensor used with LDS
Humidi-Flo DSC17000 Dual Servo Heated Humidifiers, used to
monitor the temperature in the inspiratory limb of the
breathing circuit: (a) LDS-71455 Humidifier Probe, Dual
Temperature Sensor, 40"; (b) LDS-17475 Humidifier Probe, Dual
Temperature Sensor, 60"; (c) LDS-17495 Humidifier Probe, Dual
Temperature Sensor, 72". Safety Alert #M-089/091-2.
CODE Lot numbers: 146047, 146048, 146049, 147012, 147031, 206047,
206061, 208022.
MANUFACTURER Life Design Systems (LDS), a Division of Bird Medical
Technologies, Inc., Carrollton, Texas.
ALERTED BY Manufacturer, by letter May 11, 1992.
DISTRIBUTION California, Louisiana, New York, Oho, Texas.
QUANTITY 31 probes were distributed; 14 units remain on the market, 5 of
which are used for demonstration purposes only.
REASON LDS could not recommend ETO sterilization of these probes (firm
has not validated the procedures).
SEIZURES:
PRODUCT Pulsator 2000TM electrical stimulator (92-400-792).
CHARGE Adulterated - The product is a class III medical device which
does not have in effect the required approved premarket
approval application.
Misbranded - The product is a device in package form and the
product's labeling fails to state the place of business of
the manufacturer, packer, or distributor. The device's
labeling also fails to bear adequate directions for use. It
is a prescription device for which adequate directions,
which will allow lay persons to safely or effectively use
the device, cannot be written. The device is further
misbranded because it is not listed as required.
FIRM Etna Products Company, Inc., New York, New York.
FILED June 23, 1992 - U.S. District Court for the Southern
District of New York; Civil #92 CIV 4462(CES), FDC #66380.
SEIZED August 4, 1992 - goods valued at approximately $17,900.
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PRODUCT Frozen scallops (92-639-586).
CHARGE Adulterated - The scallops consist in part of a substance,
water, which has been added thereto so as to increase its
weight to make it appear of greater value than it is.
FIRM Mar-Lees Seafood, Inc., New Bedford, Massachusetts.
FILED July 15, 1992 - U.S. District Court for the District
of Massachusetts; Civil #92-11735WF, FDC #66457.
SEIZED July 22, 1992 - goods valued at approximately $23,000.
PRODUCT Various device components used in lithotriptors (92-516-233).
CHARGE Adulterated - The products are class III medical devices
which do not have in effect the required approved
premarket approval application.
Misbranded - The products' labeling does not bear adequate
directions for use and the devices were manufactured in an
establishment that was not registered, nor were the devices
included in a list, as required by statute.
FIRM Frederick Self Storage, Frederick, Maryland.
FILED July 1, 1992 - U.S. District Court for the District
of Maryland; Civil #B-92-1849, FDC #66430.
SEIZED July 13, 1992 - goods valued at approximately $3,000.
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END OF ENFORCEMENT REPORT FOR AUGUST 19, 1992. BLANK PAGES MAY
FOLLOW.
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