Recall Z-0080-04 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Wilson-Cook Medical Inc
APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
| Date | Oct 31, 2003 (initiated Jul 25, 2003) |
| Status | Terminated |
| Reason | The label is missing the Rx Only symbol. |
| Root cause | Other |
| Action | The consignee was notified by the sales representative on/about July 29, 2003 via hand delivered letter. The consignee was informed of the recall and was advised to quarantine and return the affected product, via the Territory Manager. The consignee was urged to complete and return the response portion of the letter. |
| Quantity | 3 units |
| Distribution | Product was distributed to one account in IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.