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
07/06/1994
Recalls and Field Corrections: Foods -- Class II -- 07/06/1994
JULY 6, 1994 94-27
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Canned Chinese Mushrooms, pieces and stems, button and
whole, in #10 cans and in 16 ounce cans, under Celebrity,
Joy-Lin, Ambrosia, Roland, and Classic labels.
Recall #F-316-4.
CODE Lot numbers: 930704, 930705, 930706, 930707.
MANUFACTURER Dongguan Canning Factory, Guangdong, Peoples Republic of
China.
RECALLED BY Golden Trading Company, U.S. broker, Kurt Paine, Clearwater,
Florida, by letter January 10, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Texas, New Jersey, New York.
QUANTITY 5,296 cases (6 #10-cans per case) and 287 cases (24 16-ounce
cans per case) were distributed; firm estimates that none
remains on the market.
REASON Product contains Staphylococcal enterotoxin (SET).
_______________
PRODUCT Various frozen dough products, sold in bulk:
1. Wheat Hot Dog Roll Dough
2. French Bread Dough (generic box)
3. White Bread Dough 27 oz
4. Raisin Bread Dough
5. French Bread Dough
6. Italian Bread Dough
7. Dark Rye Bread Dough
8. White Bread Dough 18.25 oz
9. Light Rye Bread Dough w/seeds
10. Wheat Bread Dough
11. Golden Dough
12. Onion Roll Dough
13. Hot Dog Roll Dough
14. Hamburger Roll Dough
15. Submarine Roll Dough
16. Honey Oatmeal Bread Dough
17. Crusty Kaiser Roll Dough
18. Hoagie Roll Dough
19. Golden Nugget Dough
20. Deluxe Hamburger Roll Dough
21. Potato Roll Dough
22. Vienna Roll Dough
23. Petite Kaiser Roll Dough
24. Wheat Kaiser Roll Dough
25. Deluxe French Roll Dough
26. Plain Coffee Cake Dough
27. Deluxe Crusty Kaiser Roll Dough
28. Meltaway Sweet Roll Dough
29. Cinnamon Sweet Roll Dough
30. Caramel Nut Sweet Roll Dough
31. Caramel Raisin Sweet Roll Dough
32. Petite Cinnamon Sweet Roll Dough
33. Natural Grain Bread Dough
34. Pumpernickel Bread Dough
35. Brownie Dough Sheet
36. French Roll Dough
37. Shell (potato flour formulation) - Donut
38. Pershing (potato flour formulation) - Donut
39. Donut Hole-Pot Flour Form (approx ct)
40. Potato Flour Donut (ring)
41. Baguette
42. Deluxe Baguette
43. Wheat Bread Dough
44. French Onion Sandwich Bun Dough
45. Deluxe Sandwich Bun Dough
46. Coney Island Bun Dough
47. Club Roll Dough
48. Butter & Egg Dinner Roll Dough
49. Rye Dinner Roll Dough
50. Wheat Dinner Roll Dough
51. Pumpernickel Dinner Roll Dough
52. San Francisco Sour Dough Bread
53. Armesan Cheese Bread Stick Dough
54. Value Line Chocolate Chip (large) - Cookie
55. Raisin Oatmeal (large) - Cookie
56. Natural Choc Flavor Chip (large) - Cookie
57. Nat Cho Flavor Chip Oatmeal (large) - Cookie
58. Peanut Butter (large) - Cookie
-2- 59. Ranger (large) - Cookie
60. Value Line Sugar (large) - Cookie
61. Walnut Nugget (large) - Cookie
62. Value Line Oatmeal (large) - Cookie
63. Nat Cho Flavor Chip (jumbo) - Cookie
64. English Toasting Bread Dough
65. Family Pak Bread Dough
66. Cracked Wheat Bread Dough
67. Wheat French Bread Dough
68. Medium (Pizza Dough)
69. Large (Pizza Dough)
70. Light Rye Bread Dough (unseeded)
71. Deluxe Onion Roll Dough
72. Cinnamon Sweet Roll Dough with 8/1 # icing
73. Cinnamon Sweet Roll Dough w/20 oz icing
74. Honey Oat Bran Dinner Roll Dough
75. Light Seeded Rye - Bread Dough
76. Stoneground Wheat - Bread Dough
77. Honey Oatmeal Dinner Roll Dough
78. Stoneground Wheat Dinner Roll Dough
79. San Francisco Sourdough Bread
80. Cinnamon Sweet Roll (jumbo)
81. French Onion Bread Dough
82. White Bread
83. Long John (potato flour formulation) - Donut
84. White Bread Dough
85. French Bread Dough
86. Eclair Shell
87. Deluxe French Sub Roll
88. Deluxe Wheat Sub Roll
89. Classic Creamy Peanut Butter Cookie Dough
90. Bolillo Roll Dough
91. Cinnamon Loaf Dough
92. French Bread Stick Dough
93. Vegetable Bread Stick Dough
94. Walnut Nugget (homestyle)
95. Wheat Dinner Roll Dough
96. Butter and Egg Dinner Roll Dough
97. Dollar Bun Dough
98. High Fiber Cracked Wheat Bread Dough
99. Honey Oat Bran Bread Dough with Fruit
100. Dill Bread Dough
101. Potato Bread Dough
102. Vegetable Bread Dough
103. Wheat Hamburger Bun Dough
104. Choice 6-Grain Bread Dough
105. Baked Brownie
106. Cinnamon Raisin Biscuit Dough
107. Homestyle Biscuit Dough - OCB
108. Chocolate Chip (homestyle) - Cookie
109. Chocolate/Chocolate Chip (homestyle) - Cookie
110. Chocolate chip/oatmeal (homestyle) - Cookie
-3- 111. Coconut (homestyle) - Cookie
112. Molasses (homestyle) - Cookie
113. Oatmeal (homestyle) - Cookie
114. Roasted Peanut (homestyle) - Cookie
115. Creamy Peanut Butter Chip (homestyle) - Cookie
116. Raisin/Oatmeal (homestyle) - Cookie
117. Ranger (homestyle) - Cookie
118. Sugar (homestyle) - Cookie
119. Deluxe Sourdough Sub Roll Dough
120. Rye Sandwich Bun Dough
121. Gourmet Cinnamon Roll Log
122. Gourmet Cinnamon Raisin Roll Log
123. Deluxe Chocolate Chunk (bakery only) - Cookie
124. Deluxe Praline/Pecan (bakery only) - Cookie
125. Dlx Cho/Chunk Peanut Butter (bakery only) - Cookie
126. Dlx Cho/Cho Chunk/Toffee (bakery only) - Cookie
127. Deluxe Honey Raisin/Nut (bakery only) - Cookie
128. Egg Onion Roll Dough
129. Egg Kaiser Roll Dough
130. Bavarian Harvest Roll Dough
131. Classic Submarine Roll Dough
132. Coconut Macaroon Cookie
133. Candy Cookies (homestyle)
134. Deli Kaiser Roll
135. Cinnamon Raisin Biscuit Do w/2/2 oz Icing
136. Deluxe Pershing Donut Dough
137. Chocolate Chip Cookie Dough
138. Rye Sub Roll Dough
139. Wheat Sub Roll Dough
140. Maritime Brown Bread Dough
141. Rice Bran Bread with Apples and Nuts
142. French Onion Breadstick Dough
143. Hamburger Roll (ed) 200/2.75 oz
144. Biscuit Dough Homestyle
145. Biscuit Dough Homestyle
146. Pizza Dough Ball 9 oz
147. Pizza Dough Ball 13 oz
148. Pizza Dough Ball 16 oz
149. Chocolate Chunk (portioned) - Cookie
150. Honey Raisin Nut (portioned) - Cookie
151. Chocolate Chunk Peanut Butter (portioned) - Cookie
152. French Sub Roll Dough
153. Double Chocolate Chunk Gourmet Cookie Dough
154. Macadamia Nut Gourmet Cookie Dough
155. Strawberry Sheetcake Cake Crumb
156. Chocolate Chip - Cookie
157. Fancy Chocolate Chip Cookie
158. Oatmeal Raisin - Cookie
159. Peanut Butter Chocolate Chip - Cookie
160. Premium Chocolate Chip - Cookie
161. 5 oz Pizza Dough Ball
162. 31 oz Pizza Dough Ball
-4- 163. Deluxe Apple Fritter Donut Dough Logs
164. Submarine Roll Dough 5.5 oz
165. Wheat Submarine Roll Dough 5.5 oz
166. Real Chocolate Chip, Regular - Cookie
167. Raisin Oatmeal, Regular - Cookie
168. Ranger, Regular - Cookie
169. Sugar, Regular - Cookie
170. Peanut Butter, Regular - Cookie
171. Commodity Cho Chip (food service only) - Cookie
172. Commodity Oatmeal Raisin (food service only) - Cookie
173. Commodity Cho Chip (food service only) - Cookie
174. Real Chocolate Chip, Medium - Cookie
175. Raisin Oatmeal, Medium - Cookie
176. Ranger, Medium - Cookie
177. Sugar, Medium - Cookie
178. Commodity Choc Chip (food service only) - Cookie
179. Oatmeal, Medium - Cookie
180. Peanut Butter Cookie, (medium)
181. Chocolate Chocolate Chip, Large -Cookie
182. Real Chocolate Chip, Large - Cookie
183. Raisin Oatmeal, Large - Cookie
184. Ranger, Large - Cookie
185. Sugar, Large - Cookie
186. Peanut Butter, Large - Cookie
187. Walnut Nugget, Large - Cookie
188. Oatmeal, Large - Cookie
189. Real Chocolate Chip, Jumbo - Cookie
190. Raisin Oatmeal, Jumbo - Cookie
191. Ranger, Jumbo - Cookie
192. Sugar, Jumbo - Cookie
193. Peanut Butter, Jumbo - Cookie
194. Walnut Nugget, Jumbo - Cookie
195. Real Chocolate Chip, Super Jumbo - Cookie
196. Raisin Oatmeal, Super Jumbo - Cookie
197. Sugar, Super Jumbo - Cookie
198. Peanut Butter Super Jumbo (Cookie)
199. Walnut Nugget Super Jumbo (Cookie)
200. Oatmeal Super Jumbo (Cookie)
201. Brownie Fudge (Cookie)
202. Chocolate Chunk (Cookie)
203. Honey Raisin Nut (Cookie)
204. Chocolate Chunk Peanut Butter (Cookie)
205. Chocolate Chunk pecan (Cookie)
206. Butter Pecan (Cookie)
207. Baked, Scored - Brownie Half Sheet
208. Golden Corrall Breadstick Dough
209. Vegetable Pizza Dough - 16 oz
210. Golden Pound Cake
211. 1/4 Sheet White Cake Uniced
212. 1/4 Sheet Chocolate Flavor Cake Uniced
213. 1/4 Sheet Yellow Cake Uniced
214. Chocolate Flavor Cake Roll Iced
-5- 215. Filled Cream Puff
216. Chocolate Roll - Cake
217. Chocolate Chip Blondie Baked Half Sheet - Cake
218. Filled Eclair
219. Petite Custard Creme Puff
220. Petite Custard Eclair
221. Parkerhouse Rolls
222. Dinner Rolls
223. Hard Rolls
224. Buttermilk Biscuits
225. Individual Baked Brownie
226. Baked Brownie Half Sheet
227. 1/4 Sheet Marble Cake Uniced
228. Cream Puff Shell
229. Bite-Size Cream Puff Shell
230. Bite-Size Eclair Shell
231. Lemon Roll
232. Baked Cinnamon Roll 8/12 2.75 Oz
233. Baked Cinnamon Danish Rolls (petite)
234. Cobbler Crust Dough Sheets
235. Chocolate Uniced Half Sheet Cake (foil pan)
236. Yellow Uniced Half Sheet Cake (foil pan)
237. White Uniced Half Sheet Cake (foil pan)
238. Little King's French Sub Roll (Dough)
239. Perkin 10.5 oz Italian Bread Bowl Dough
240. Perkins French Onion Bread Bowl Dough
241. Perkins French Bread Dough
242. Perkins White Bread Dough
243. Perkins Wheat Bread Dough
244. Perkins Light Rye Bread Dough
245. Perkins Cinnamon Roll Dough
246. Perkins Kaiser Sandwich Roll Dough
247. Perkins Eclair Shell
248. Baskin Robbins Chocolate Roll Cake
249. Baskin Robbins White Roll Cake
250. Baskin Robbins Chocolate Uniced Cake
251. Caseys Brownie - Baked and Portioned
252. Caseys Jumbo Cinnamon Roll Dough
253. Caseys Chocolate Chunk Cookies (Dough)
254. Caseys Honey Raisin Nut Cookies (Dough)
255. Caseys Jumbo Sugar Cookies (Dough)
256. Metromedia Raisin Bread Dough
257. Rich's Walt Disney World Pizza Dough
258. KFC Cobbler Crust Dough Sheets
259. Aafes Pizza Dough
260. Rich's Enriched White Bread Dough - 2 loaves
261. Rich's Enriched White Bread Dough - 5 loaves
262. Rich's Baked Cinnamon Rolls
263. Simek's Cinnamon Roll Dough
264. Raspberry Flavored Filled Jelly Roll
265. Rich's Jelly Roll Slice with Raspberry Filling 266.
266. Rich's Danish Pastry. Recall #F-438/703-4.
-6- CODE All codes of A4095 and below. Products manufactured between
5/12/93 and 4/5/94.
MANUFACTURER Rich Products Corporation, Appleton, Wisconsin.
RECALLED BY Rich Products Corporation, Buffalo, New York, by memorandum
and by letter dated April 7, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimated 250,000 cases of product remained on market
at time of recall.
REASON Products contain pieces of metal fragments.
_______________
PRODUCT Fresh Escolar Fish. Recall #F-709-4.
CODE None.
MANUFACTURER Inland Seafood, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone May 26, 1994. Firm-initiated
recall complete.
DISTRIBUTION Georgia, Alabama, North Carolina, South Carolina, Tennessee.
QUANTITY Approximately 250 pounds were distributed; firm estimated
less than 10 pounds remained on market at time of recall.
REASON Product is decomposed and contains histamines.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Jewel Crispy Rice Vitamin Fortified Cereal, in 13 ounce
boxes. Recall #F-707-4.
CODE 6OCT1794.
MANUFACTURER Malt-O-Meal Company, Northfield, Minnesota.
RECALLED BY Manufacturer, by telephone May 23, 1994. Firm-initiated
recall complete.
DISTRIBUTION Illinois, Indiana, Iowa, Michigan.
QUANTITY 960 cases (12 boxes per case) were distributed.
REASON Product contains undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
=====================
_______________
PRODUCT Aloe Vesta Skin Cream with Aloe Vera, in 4 fluid ounce
bottles, a topical cream labeled for use by health care
staff, patients and residents to smooth and moisturize
rough, dry skin. Recall #F-708-4.
CODE Lot #205064.
MANUFACTURER Calgon Vestal Laboratories, Inc., St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone April 8, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 19,440 bottles were distributed.
REASON Product is contaminated with Pseudomonas cepacia.
-7- _______________
PRODUCT Aloe Vesta Skin Cream kits contained in the following
hospital admission kits, packed 12 kits per case: (a) Admit
kit, Catalog #ADM24-8208; (b) Holy Family Admission Kit,
Catalog #ADM-31-3692; (c) Proctor Admission Kit, Catalog
#ADM31-7197; (d) Admission Kit, Catalog #ADM888A0802; (e)
Admission Kit, Catalog #ADM10-698B. Recall #F-710/714-4.
CODE All kits packaged between 3/11/94 and 4/11/94.
MANUFACTURER Calgon Vestal Laboratories, Inc., St. Louis, Missouri (skin
cream manufacturer).
RECALLED BY Baxter Healthcare Corporation, Hospital Sale and
Distribution Division, McGaw Park, Illinois, by letter April
14, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, Louisiana, Illinois, Arkansas.
QUANTITY 4,956 kits were distributed; firm estimated 50% of product
remained on market at time of recall.
REASON Product was contaminated with Pseudomonas cepacia bacteria.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
______________
PRODUCT Phendimetrazine Tartrate 35 mg Green Tablet, (X-Trozine), in
bottles of 1000, Rx for the management of exogenous obesity.
Recall #D-316-4.
CODE Lot Number EXP Date Lot Number EXP Date
B3713 4/99 B3472 9/97
B3346 11/96 B3195 9/95
B3679 1/96 B3459 8/97
B3342 11/96 B3194 9/95
B3678 1/99 B3458 8/97
B3324 9/96 B3153 5/95
B3646 9/98 B3456 7/97
B3301 7/96 B3149 5/95
B3639 9/98 B3442 6/97
B3294 6/96 B3148 5/95
B3638 9/98 B3434 5/97
B3274 5/96 B3139 4/95
B3592 5/98 B3426 5/97
B3243 2/96 B3138 4/95
B3589 5/98 B3410 4/97
B3223 11/95 B3126 1/95
B3586 4/98 B3381 1/97
B3212 11/95 B3125 1/95
B3562 3/98 B3376 1/97
B3205 10/95 B3108 11/94
B3507 12/97 B3366 12/96
B3196 10/95 B3107 11/94
B3506 12/97 B3365 12/96.
MANUFACTURER Richwood Pharmaceutical Company, Inc., doing business as
Rexar Pharmacal Corporation, Valley Stream, New York.
RECALLED BY Manufacturer, by telephone June 2, 1994. Firm-initiated
recall ongoing.
-8- DISTRIBUTION California, Indiana, Maine, Missouri, New Jersey, New York,
Pennsylvania.
QUANTITY Approximately 6,750 units of 1000 tablets were distributed.
REASON Product contains undeclared FD&C Yellow #5.
_______________
PRODUCT Erb-Kan-Trol, also known as Xiaokewan, 0.25 mg pills, a
nonprescription oral medication recommended for the control
of diabetes, in bottles of 30. Recall #D-319-4.
CODE None.
MANUFACTURER Guangzhou Medicines & Health Products, China.
RECALLED BY Cureall, Inc., Toledo, Ohio, by telephone June 15, 1994, and
by letter dated June 15, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,222 bottles were distributed.
REASON Product was marketed without new drug approval.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Sulfadiazine Tablets, 500 mg, in bottles of 100 and 1000, Rx
antibacterial, under the Richlyn label as Sulfadiazine and
under the Consolidated Midland Corp. label as Microsulfon.
Recall #D-317-4.
CODE Lot numbers: 44800 EXP 4/95 (Richlyn label); 45038 EXP 8/95
(Consolidated Midland label).
MANUFACTURER Richlyn Laboratories, Inc., Philadelphia, Pennsylvania.
RECALLED BY Global Pharmaceutical Corporation, Philadelphia,
Pennsylvania, by telephone June 15, 1994, followed by fax
June 27, 1994. Firm-initiated recall ongoing.
DISTRIBUTION New York, California, Connecticut, Florida, Georgia,
Maryland, Michigan, New Jersey.
QUANTITY Firm estimates very little product remains in commerce.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Flurazepam HCl Capsules, USP, 15 mg, in bottles of 100,
useful in the treatment of insomnia. Recall #D-318-4.
CODE Lot #36253L EXP 5/95.
MANUFACTURER Warner Lambert Company, Warner Chilcott Laboratories
Division, Lititz, Pennsylvania.
RECALLED BY Warner Lambert Company, Warner Chilcott Laboratories
Division, Morris Plains, New Jersey, by letter May 26, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,232 bottles were distributed; firm estimates very little
product remains on the market.
REASON Product does not meet dissolution specifications.
-9- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Ambulatory Syringe Pumps: (a) Model MS16A; (b) Model MS26.
Recall #Z-975/976-4.
CODE (a) All units up to and including serial number 23390;
(b) All units up to and including serial number 13570.
MANUFACTURER Graseby Medical, Ltd., Watford, Herts, England.
RECALLED BY MarCal Medical Inc., Millersville, Maryland, by letter
January 24, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,618 units.
REASON The alarm sounder retention pin is undersize and if broken
may cause a risk of overinfusion.
_______________
PRODUCT Argon Brand Drape Packs containing laparotomy sponges as one
of the accessories, for use in hospital catheter/radiology
laboratories. Recall #Z-985/1003-4.
CODE Reorder Nos. Lot Nos.
398342F M887560;
398342G M908190, M932390, M942420;
398342H M949810, M974370, M991580, MDL9130;
398342I M010810, M012120, 93014560, 93021024,
93021025, 93022948, 93046754, 93047752,
93052165, 93070957, 93077084, 93081142,
93090528, 93097375, 93100010R;
398342J 93120456;
398465A M882310, M901670, M916280;
398465B M950000, M981770;
398465C M014570, M022860, 93014579, 93022977,
93025103;
398465D 93070963, 93070964, 93070965;
398465E 93091245, 93091246, 93091247, 93102993,
93114495R;
399021 93073212, 93111036, M970150, M991790;
399088 M807480;
399436 M92180;
399491 M946910;
399681 93013758;
399681A 93015117, 93043394;
399841 93059196;
399963 93115697;
399999* 93120005.
MANUFACTURER Kendall Healthcare Products Company, Mansfield,
Massachusetts (repacked sponges).
RECALLED BY Argon, Div. of Maxim Medical, Athens, Texas, by letter May
31, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Louisiana, Missouri, Nebraska, Ohio,
Virginia.
QUANTITY 1,274 units were distributed between 6/29/91 and 1/18/94.
REASON Sponges may not be sterile.
-10- _______________
PRODUCT Various Sterile Custom Procedure Kits and Trays,
Sterilization/Production Lots 488, 495, 496, 505, 506.
Recall #Z-1004/1022-4:
(a) Suture Removal Trays, Reorder #101L, #116; Catalog
#STD-708, #STD-713, #STD-717, #STD-736;
(b) Wound Closure Trays, Reorder #230; Catalog #611, #685,
#893;
(c) Laceration Trays, Catalog #STD-655, #661, #675, #694,
#727, #3-750, #772, #823-FH, #828, #864, #949, #956, #968;
(d) Dressing Trays, Reorder #510; Catalog #574, #575, #755,
#758, #779, #781, #789, #813, #878, #889A, #920, #948,
#5091;
(e) Central Line Kit, Catalog #533;
(f) Derf Needleholder, Catalog #572;
(g) Instrument Tray, Catalog #642-RM;
(h) Raytec Sponge Kit, Catalog #762;
(i) CVC Insertion Tray, Catalog #810;
(j) Dialysis Kit, Catalog #861;
(k) All Purpose Tray, Catalog #880A;
(l) CVL Tubing Change Tray, Catalog #890;
(m) Plastic Tray, Catalog #980;
(n) I.V. Start Kit, Catalog #992;
(o) Utility Drape 40" x 36", Medical Associates
International, Inc. Reorder #2000;
(p) Utility Drape 40" x 72", Medical Associates
International, Inc. Reorder #2001;
(q) Baxter Straight Kelly Hemostat, Baxter Healthcare
Catalog No. 35048-002;
(r) Baxter Webster Needle Holder, Baxter Healthcare Catalog
No. 35048-007;
(s) Baxter Sharp/Blunt Scissors, Baxter Healthcare Catalog
No. 35048-150.
CODE Sterilization/Production Lot 488, 495, 496, 505, 506.
MANUFACTURER Sterling Medical Products, Prophetstown, Illinois.
RECALLED BY Manufacturer, by telephone, fax, and letter May 31, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Michigan, Illinois, Pennsylvania, Massachusetts, New York,
Alabama, Kansas.
QUANTITY 573 cases were distributed; firm estimates that 50% of
product remained on market at time of recall.
REASON The sterility of the devices may be compromised due to lack
of package integrity and possible lack of adequate
sterilization.
_______________
PRODUCT Various Sterile Custom Procedure Kits and Trays,
(a) Suture Removal Tray, Reorder No. 101L; and Catalog No.
STD-736;
(b) Suturing Set, Catalog No. 29;
(c) Central Line Kit, Catalog No. 533;
(d) Small Dressing Tray, Catalog No. 543;
-11- (e) Large Dressing Tray, Catalog No. 544;
(f) Instrument Set, Catalog No. STD-722;
(g) Laceration Tray, Catalog No. 786;
(h) E.R. Laceration Tray, Catalog No. 828;
(i) Central Line Dressing Tray, Catalog No. 846;
(j) Suture Removal Kit, American Healthcare Products Catalog
No. 839315;
(k) All Purpose Instrument Tray, American Healthcare
Products Reorder No. AHP-GP104;
(l) Webster Needleholder, American Healthcare Products
Catalog No. AHP-WEBSTER;
(m) Wire Cutters, American Healthcare Products Catalog No.
AHP-Wirecut. Recall #Z-1023/1035.
CODE Sterilization/production lot 504.
MANUFACTURER Sterling Medical Products, Prophetstown, Illinois.
RECALLED BY Manufacturer, by telephone, fax, and letter June 7, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Illinois, Washington state.
QUANTITY 83 cases were distributed; firm estimated that 50% of
product remained on market at time of recall.
REASON Some devices in this sterilization/production lot were found
to be non-sterile.
_______________
PRODUCT Argyle Yankauer Suction Tube, Rigid Type, Regular Capacity:
(a) Regular Capacity with Bulbous Tip, Catalog No.
8888-505016;
(b) Regular Capacity with Bulbous Tip with Tip-Trol,
Catalog No. 8888-505024;
(c) Regular Capacity with Open Tip, Catalog No.
8888-505115;
(d) Regular Capacity with Open Tip with Tip-Trol, Catalog
No. 8888-505123. Recall #Z-1036/1039-4.
CODE Lot Numbers: (a) 700198, 737290, 737291, 737597, 737598,
737599, 737857, 737858, 737859, 737954, 738114, 738115,
738244, 738245, 738246, 738247, 738248, 738261;
(b) 700166, 700167, 700169, 737292, 737353;
(c) 700170, 700171, 737293, 737355, 737861;
(d) 738329.
MANUFACTURER Sherwood Medical Company, Commerce, Texas.
RECALLED BY Sherwood Medical Company, St. Louis, Missouri, by letter
April 28, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Australia, Hong Kong, Mexico, Chile.
QUANTITY (a) 1,106,550; (b) 183,000; (c) 167,600; (d) 23,100 units
were distributed.
REASON The product was improperly sealed thus compromising the
sterility of the device.
-12- _______________
PRODUCT Lusee Steerable Guidewire with SLX Coating, Class II medical
devices designed for use in the introduction and placement
of dilatation catheters in the coronary vasculature and for
peripheral procedure requiring a steerable system:
(a) Catalog #552-141; (b) Catalog #552-141J;
(c) Catalog #552-142; (d) Catalog #552-142J;
(e) Catalog #552-142X; (f) Catalog #552-143;
(g) Catalog #552-143J; (h) Catalog #552-143X.
Recall #Z-1040/1047-4.
CODE All lots.
MANUFACTURER Cordis Corporation, Miami Lakes, Florida.
RECALLED BY Manufacturer, by letter May 3, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 16,977 units were distributed.
REASON The distal tips of the guidewires may fracture and separate.
_______________
PRODUCT Nezhat-Dorsey Reusable Electrosurgical Probes:
(a) Threaded-Base Claw Electrode, Catalog No. 1044C;
(b) Quick-Disconnect Claw Electrode, Catalog No. 1044CQD;
(c) Threaded-Base Zucker Hook/Spatula Electrode, Catalog No.
1044H;
(d) Quick-Disconnect Zucker Hook/Spatula Electrode, Catalog
No. 1044HQD;
(e) Threaded-Based L-hook Electrode, Catalog No. 1044L;
(f) Quick-Disconnect L-Hook Electrode, Catalog No. 1004LQD;
(g) Threaded-Based Corbitt Spatula Electrode, Catalog No.
1044S;
(h) Quick-Disconnect Corbitt Spatula Electrode, Catalog No.
1044SQD;
(i) Threaded-Based J-Hook Electrode, Catalog No. 1044SH;
(j) Quick-Disconnect J-Hook Electrode, Catalog No. 1044SHQD.
Recall #Z-1049/1058-4.
CODE All codes.
MANUFACTURER American Hydro Surgical, Delray Beach, Florida.
RECALLED BY Manufacturer, by letter April 5, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,087 probes were distributed.
REASON Probe tips have the potential to separate from the probe
cannula during use.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Smith & Nephew Dyonics Arthroscopic Surgery Blade, 4.5 mm
curved full radius concave blade, disposable, used with the
PS3500EP Motor Drive Unit (Catalog No. 3476) or with the
Universal Autosensor (Catalog No. 3492) in the Universal
Motor Drive Unit (Catalog No. 3124). Recall #Z-972-4.
-13- CODE Lot number 277484, also referred to as (M) 277484 on package
label.
MANUFACTURER Smith & Nephew Dyonics, Inc., Andover, Massachusetts.
RECALLED BY Manufacturer, by visit on or about December 16, 1993.
Firm-initiated recall complete.
DISTRIBUTION Alabama, Connecticut, Florida, Louisiana, Michigan,
Massachusetts, Pennsylvania, New York, Tennessee, Texas.
QUANTITY 126 blades were distributed.
REASON The window/curve orientation of the 4.5 mm arthroscopic
surgery blade, Catalog #4474, was identified as Catalog
#4349.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT Bulk Lean Generation #543 Special Mixed Swine Feed with
Fenbendazole, medicated premix swine dewormer.
Recall #V-053-4.
CODE Lot numbers: 019953, 020329
MANUFACTURER Purina Mills, Inc., Montgomery City, Missouri.
RECALLED BY Purina Mills, St. Louis, Missouri, by verbally informing
customer on or about April 20, 1994. Firm-initiated recall
complete.
DISTRIBUTION Missouri.
QUANTITY 6,034 pounds of lot 019953, and 6,012 pounds of lot 020329
were distributed.
REASON Feed is superpotent due to a formulation error.
-14-
END OF ENFORCEMENT REPORT FOR JULY 6, 1994. BLANK PAGES MAY FOLLOW.
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