Recall Z-1106-04 ยท GBO Catheter, Nephrostomy, General & Plastic Surgery
Boston Scientific Corp
Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; model no. M001906885.
| Date | Jul 20, 2004 (initiated Jun 25, 2004) |
| Status | Terminated |
| Reason | Mislabeled as to size; 10FR are labeled as 8FR. |
| Root cause | Other |
| Action | The firm hand delivered the recall notification to the consignee hospital on 6/30/04. Product at the customer have been relabeled by the firm. |
| Distribution | Missouri. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820867 | PERCUTANEOUS NEPHROSTOMY SET Van-Tec, Inc., Apr 13, 1982 |