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
- Company
- Wilson-Cook Medical Inc
- Recall Initiated
- July 25, 2003
- Posted
- October 31, 2003
- Terminated
- December 4, 2003
- Recall Number
- Z-0080-04
- Quantity
- 3 units
- Firm Location
- Winston-Salem, NC
Reason for Recall
The label is missing the Rx Only symbol.
Distribution
Product was distributed to one account in IL.
Lot / Code Info
Reorder #ZPSOF-7-4-RB, Lot #1615857, 1600284, 1600285.
Root Cause
Other
Action Taken
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.
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