FDA Recall
Terminated
Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).
Recall: Z-0029-04
·
Initiated September 5, 2003
Recall
- Recall Number
- Z-0029-04
- Event Number
- 27225
- Firm
- Dow Corning Corp.
- FEI Number
- 1824893
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 5, 2003
- Posted
- October 15, 2003
- Terminated
- February 11, 2004
- Address
- 12334 Geddes Rd., Hemlock, MI, 48626
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
May be contaminated with iron, chromium and nickel from stainless steel equipment failure during manufacture.
Action
Customers were notified via phone call and by letter dated September 5, 2003. Customer were asked to return unused materials.
Distribution
United States.
Quantity
2300