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U.S. Department of Health and Human Services

Class 2 Device Recall WilsonCook Endoscopic Clipping Device

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  Class 2 Device Recall WilsonCook Endoscopic Clipping Device see related information
Date Initiated by Firm June 07, 2011
Date Posted June 28, 2011
Recall Status1 Terminated 3 on May 15, 2012
Recall Number Z-2691-2011
Recall Event ID 59039
510(K)Number K023903  
Product Classification Ligator, Esophageal - Product Code MND
Product Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical

Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations.
Code Information Lot numbers: W2965637, W2976210, W2978497, W2983595, W2986018, W2987394, W2987969, W2990400, and W2998860.
Recalling Firm/
Manufacturer		 Cook Endoscopy
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information Contact Customer Relations,
800-457-4500
Manufacturer Reason
for Recall		 The disposable clip may not deploy after being positioned inside the patient.
FDA Determined
Cause 2		 Device Design
Action Wilson-Cook Medical, Inc. (Cook Endoscopy) sent an "URGENT: PRODUCT RECALL" notice dated June 7, 2011 and a "PRODUCT RECALL EFFECTIVENESS SURVEY' dated June 21, 2011 to all affected consignees. The notice described the product, problem, and actions to be taken. Medical users were instructed to quarantine any affected products and return to Cook Medical. The distributors were instructed to contact their customers and coordinate the return of the affected products to Cook Medical. The recalled notice and survey should be completed and returned to Cook Medical via fax to 812-339-7316 or scanned and emailed to CustomerRelationsNA@cookmedical.com. If you have any questions regarding this matter, please contact the Customer Relations Department at toll free-1-800-457-4500, press 4 then enter extension 2146 or by email at CustomerRelationsNA@cookmedical.com .
Quantity in Commerce 307 units
Distribution (USA) Nationwide Distribution including the states of: CA, HI, MA, ME, NC and NY.
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 = MND and Original Applicant = WILSON-COOK MEDICAL, INC.
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