Recall Z-0931-05 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Boston Scientific Scimed
PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.
| Date | Jun 25, 2005 (initiated Apr 19, 2005) |
| Status | Terminated |
| Reason | Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength. |
| Root cause | Other |
| Action | Recall letters letters were sent to all customers on 4/19/2005 with instructions to discontinue using the identified felt products. |
| Quantity | 290 packs containing 5 pieces of Felt. |
| Distribution | The product was distributed to hospitals nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.