Recall Z-1059-2009 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cook Endoscopy
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.
| Date | Mar 10, 2009 (initiated Jan 21, 2009) |
| Status | Terminated |
| Reason | The snare head is hexagonal but the handle and packaging indicate an oval reorder number. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 10 boxes (100 snares) |
| Distribution | Worldwide Distribution -- USA including states of MI, NY, and WI and country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851958 | ROTATABLE POLYPECTOMY SNARE POS-1 Wilson-Cook Medical, Inc., Jul 25, 1985 |