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U.S. Department of Health and Human Services

Class 2 Device Recall WilsonCook 10 Shot MultiBand Ligator

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  Class 2 Device Recall WilsonCook 10 Shot MultiBand Ligator see related information
Date Initiated by Firm September 03, 2010
Date Posted October 19, 2010
Recall Status1 Terminated 3 on March 31, 2011
Recall Number Z-0091-2011
Recall Event ID 56808
510(K)Number K974018  
Product Classification Ligator, hemmorrhoidal - Product Code FHN
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Cook Endoscopy
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information Contact Customer Relations
80-457-4500
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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, 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FHN and Original Applicant = WILSON-COOK MEDICAL, INC.
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