Recall Z-0081-2007 ยท FFA Tube, Drainage, Suprapubic
Boston Scientific Corp
Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350.
| Date | Oct 28, 2006 (initiated Sep 21, 2006) |
| Status | Terminated |
| Reason | Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed. |
| Root cause | Other |
| Action | Consignees were notified by letter dated 9/21/06 to discontinue use of recalled product, and to segregate the recalled product, and to follow instructions for responding to the firm and returning the product. |
| Quantity | 80 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944290 | CATHETERS, BILIARY CATHETERS, UROLOGICAL Boston Scientific Corp, Dec 8, 1994 |