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
FDA Recall Z-0080-04 · Posted 2003-10-31
Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2003-07-25
Date Terminated2003-12-04
Product Quantity3 units
Reason for Recall
The label is missing the Rx Only symbol.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was distributed to one account in IL.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.