Z-1059-2009

AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy, 4900 Bethania...

Name: Z-1059-2009 AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy, 4900 Bethania...
Creator: Cook Endoscopy
Published: 2009-01-21
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2009-01-21 / Terminated / root cause: manufacturing process

FDA source

Cook Endoscopy began a recall of AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, packed 5 boxes... on 2009-01-21. The reason FDA records is "The snare head is hexagonal but the handle and packaging indicate an oval reorder number". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1059-2009
Status: Terminated
Initiated: 2009-01-21
Posted: 2009-03-10
Terminated: 2010-04-06
Recalling firm: Wilson-Cook Medical Inc.
Product: 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.
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: The snare head is hexagonal but the handle and packaging indicate an oval reorder number.
Root cause tag: manufacturing process
FDA 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 in commerce: 10 boxes (100 snares)
Distribution: Worldwide Distribution -- USA including states of MI, NY, and WI and country of Australia.
Product codes and lots: Lot number: W23594445 and W2594446, Exp. Date: 10-2011

Product code KNS

K851958Class IIRotatable Polypectomy Snare Pos-1Wilson-Cook Medical, Inc. / cleared 1985-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)