Recall Z-0116-2008 ยท FFF Cover, Biopsy Forceps
Boston Scientific Corporation
Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 U PN Number: M00513321 REF: 1332-20
| Date | Oct 31, 2007 (initiated Aug 28, 2007) |
| Status | Terminated |
| Reason | Device lacked manufacturing finishing process resulting in endoscope damage. |
| Root cause | Process control |
| Action | Boston Scientific notified accounts by letter on 8/28/07 by Federal Express Priority mail. Accounts are requested to remove product from inventory and return product. |
| Quantity | 145 boxes |
| Distribution | Worldwide, including USA, Sweden, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.