AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, packed 5 boxes, 10 units per box. This device is used with an electrosurgical unit for endoscopic polypectomy.
This recall has been terminated (originally issued March 10, 2009).
- Company
- Cook Endoscopy
- Recall Initiated
- January 21, 2009
- Posted
- March 10, 2009
- Terminated
- April 6, 2010
- Recall Number
- Z-1059-2009
- Quantity
- 10 boxes (100 snares)
- Firm Location
- Winston Salem, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The snare head is hexagonal but the handle and packaging indicate an oval reorder number.
Distribution
Worldwide Distribution -- USA including states of MI, NY, and WI and country of Australia.
Lot / Code Info
Lot number: W23594445 and W2594446, Exp. Date: 10-2011
Root Cause
Process control
Action Taken
Consignees were notified via USPC, Certified Mail and email on/about 1/21/2009 with an Urgent - Product Recall Notice. The distributor (Cook Australia) was instructed to return quarantined product to Cook Endoscopy. All medical users were instructed to review the attached list and quarantine any affected product remaining at their facility. They were to complete the form at the bottom of the page and send/fax it. Users are to return any affected product to Cook Endoscopy. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed.