PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M0020001939
FDA device recall Z-0931-05 · posted 2005-06-25 · Terminated
Recall details
- Recalling firm
- Boston Scientific Scimed
- Reason for recall
- Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.
- Action taken
- Recall letters letters were sent to all customers on 4/19/2005 with instructions to discontinue using the identified felt products.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXZ
- Quantity affected
- 290 packs containing 5 pieces of Felt.
- Distribution
- The product was distributed to hospitals nationwide.
- Date initiated
- 2005-04-19
- Date posted
- 2005-06-25
- Date terminated
- 2006-10-03
- Location
- Maple Grove, MN
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