Recall Z-0091-2011 ยท FHN Ligator, Hemorrhoidal
Cook Endoscopy
Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105 This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
| Date | Oct 19, 2010 (initiated Sep 3, 2010) |
| Status | Terminated |
| Reason | A section of the ligator barrel may separate from the barrels friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator barrel detaching inside the patients gastrointestinal tract. |
| Root cause | Other |
| Action | COOK Endoscopy sent an URGENT: PRODUCT RECALL dated September 3, 2010, via USPS Certified Mail and by email to all consignees. The letter identified the products, the problem, and the action to be taken by the consignees. All consignees were instructed to quarantine any affected product and return them to Cook Medical. Distributors were instructed to contact their customers and coordinate the return of the affected product to Cook Medical. Within 2 weeks of the initial recall notification, Level B effectiveness checks (40% of the total number of consignees) will be conducted. These custome |
| Quantity | 2011 units (total including both 6 & 10 Shooters) |
| Distribution | Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, WA, WI, WV, and WY; and the countries of Algeria, Australia, Austria, Belgium, Canada, Chile, Cyprus, Den |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974018 | WILSON-COOK 10 SHOT MULTI-BAND LIGATOR Wilson-Cook Medical, Inc., Jan 20, 1998 |