Medical Device Recall: Z-0029-04

FDA Recalls dataset · Firm: Dow Corning Corp. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-09-05 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0029-04.

Recall Res Number
Z-0029-04
Recalling Firm / Manufacturer
Dow Corning Corp.
FEI Number
1824893
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-09-05
Date Posted
2003-10-15
Date Terminated
2004-02-11
Product Code
N/A
Event Number
27225
Product Quantity
2300
Product Description Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).
Reason for Recall May be contaminated with iron, chromium and nickel from stainless steel equipment failure during manufacture.
Action Details Customers were notified via phone call and by letter dated September 5, 2003. Customer were asked to return unused materials.
Distribution Pattern United States.
Code Information / Serial Numbers material number 3242901; lots 0001531727, 001583486 and 0001671243. material number 3242897; lot 0001604743.

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