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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm September 05, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on February 11, 2004
Recall Number Z-0029-04
Recall Event ID 27225
Product Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).
Code Information material number 3242901; lots 0001531727, 001583486 and 0001671243. material number 3242897; lot 0001604743.
Recalling Firm/
Manufacturer		 Dow Corning Corp.
12334 Geddes Rd.
Hemlock MI 48626
For Additional Information Contact
989-496-1680
Manufacturer Reason
for Recall		 May be contaminated with iron, chromium and nickel from stainless steel equipment failure during manufacture.
FDA Determined
Cause 2		 Other
Action Customers were notified via phone call and by letter dated September 5, 2003. Customer were asked to return unused materials.
Quantity in Commerce 2300
Distribution United States.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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