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.
This recall has been terminated (originally issued October 19, 2010).
- Company
- Cook Endoscopy
- Recall Initiated
- September 3, 2010
- Posted
- October 19, 2010
- Terminated
- March 31, 2011
- Recall Number
- Z-0091-2011
- Quantity
- 2011 units (total including both 6 & 10 Shooters)
- Firm Location
- Winston Salem, NC
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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, Denmark, France, Georgia, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Jordan, Korea, Mexico, Malaysia, Morocco, Netherlands, New Zealand, Peru, Poland, Portugal, South Africa, Slovakia, Spain, Switzerland, United Arab Emirates, UK and Venezuela.
Lot / Code Info
Product Order Number: MBL-10, Lot No. W2758471, W2758472, W2758474, W2760365, 2760366, 2760380, W2763652, W2764330, W2764331, W2764332, W2772073, W2772074 and W2772075; MBL-10-F, Lot No. W2763624, W2763626, W2763634, W2767450, W2768607, W2768615, W2768616, W2768617, W2770052, W2773557 and W2773558; MBL-10-I, Lot No. W2767442; MBL-10-XS, Lot No. W2787044, W2795540 and W2796313.
Root Cause
Other
Action Taken
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 customers will receive a recall effectiveness survey. All non-responding consignees will receive a total of 3 recall notifications (2 follow-up requests for a response in addition to the initial recall notification. Monthly status reports regarding this recall will be provided to FDA. All devices returned as part of this recall will be destroyed by the recalling firm upon receipt of authorization to do so by FDA. Forty percent (40%) of total customers affected received a second notice on 9/17/2010 as part of the effectiveness checks. As of 9/21/2010, 38% of all affected customers have responded. For questions contact the Customer Relations Department at CustomerRelationsNA@cookmedical.com or call 1-800-457-4500, press 4 then enter extension 2146.