Recall Z-1499-06 ยท GBW Catheter, Peritoneal
Boston Scientific Corp
Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201.
| Date | Sep 13, 2006 (initiated Aug 10, 2006) |
| Status | Terminated |
| Reason | Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge. |
| Root cause | Other |
| Action | Consignee was notified via letter 8/10/06 to discontinue use of the product and to return it to the firm. |
| Quantity | 4 units |
| Distribution | Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811378 | PERCUTANEOUS DRAINING CATHETER Medi-Tech, Inc., Jun 2, 1981 |