AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Win
FDA device recall Z-1059-2009 · posted 2009-03-10 · Terminated
Recall details
- Recalling firm
- Cook Endoscopy
- Reason for recall
- The snare head is hexagonal but the handle and packaging indicate an oval reorder number.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KNS
- Quantity affected
- 10 boxes (100 snares)
- Distribution
- Worldwide Distribution -- USA including states of MI, NY, and WI and country of Australia.
- Date initiated
- 2009-01-21
- Date posted
- 2009-03-10
- Date terminated
- 2010-04-06
- Location
- Winston Salem, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROTATABLE POLYPECTOMY SNARE POS-1 (K851958) | Wilson-Cook Medical, Inc. | 1985-07-25 |