510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0092-2011

Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem...

Wilson-Cook Medical Inc. / initiated 2010-09-03 / Terminated
FDA source (opens on fda.gov)

Cook Endoscopy began a recall of Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105 This device is used to endoscopically... on . The reason FDA records is "A section of the ligator barrel may separate from the barrel's 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 patient's...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0092-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Wilson-Cook Medical Inc.
Product
Six 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.
Product code
MND Ligator, Esophageal
Reason for recall
A section of the ligator barrel may separate from the barrel's 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 patient's gastrointestinal tract.
FDA 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 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 [email protected] or call 1-800-457-4500, press 4 then enter extension 2146.
Quantity in commerce
see line one
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.
Product codes and lots
Product Order Number: MBL-10, Lot No. W2758471, W2758472, W2758474, W2760365, 22760366, 22760380, 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.