PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.
- Company
- Boston Scientific Scimed
- Recall Initiated
- April 19, 2005
- Posted
- June 25, 2005
- Terminated
- October 3, 2006
- Recall Number
- Z-0931-05
- Quantity
- 290 packs containing 5 pieces of Felt.
- Firm Location
- Maple Grove, MN
Reason for Recall
Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.
Distribution
The product was distributed to hospitals nationwide.
Lot / Code Info
Lot Numbers: 7337514; 7337515; 7337516; 7337717; 7350604; 7356745; 7356747; 7359759; 7359760; 7360535; 7360536; 7384480; 7384483; 7384484; 7384485; 7384486; 7384487; 7412113.
Root Cause
Other
Action Taken
Recall letters letters were sent to all customers on 4/19/2005 with instructions to discontinue using the identified felt products.
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