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U.S. Department of Health and Human Services

Class 2 Device Recall Cooper Surgical

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  Class 2 Device Recall Cooper Surgical see related information
Date Initiated by Firm March 20, 2015
Date Posted May 19, 2015
Recall Status1 Terminated 3 on July 29, 2015
Recall Number Z-1630-2015
Recall Event ID 70828
510(K)Number K133414  
Product Classification endoscope laparoscope accessory - Product Code NLM
Product Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
Code Information Lot 174422
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Customer Service
203-601-9818
Manufacturer Reason
for Recall		 The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad printing flaking off around the entry holes.
FDA Determined
Cause 2		 Component design/selection
Action Consignees were notified of the recall by letter sent via FedEx dated March 20, 2015. The letter instructs consignees to do the following: discontinue use of the affected product, complete the attached acknowledgement and receipt form to return the product and schedule a replacement.
Quantity in Commerce 430 units
Distribution US Nationwide distribution.
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 = NLM and Original Applicant = STERILMED, INC.
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