PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.
This recall has been terminated (originally issued June 25, 2005).
- 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
- Official Source
- View on FDA website ↗
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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