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U.S. Department of Health and Human Services

Class 2 Device Recall Blunt Hurd CannulaBlunt Tip 10mm with 5mm Reducer

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  Class 2 Device Recall Blunt Hurd CannulaBlunt Tip 10mm with 5mm Reducer see related information
Date Initiated by Firm September 13, 2013
Date Posted October 29, 2014
Recall Status1 Terminated 3 on September 23, 2015
Recall Number Z-0147-2015
Recall Event ID 69446
510(K)Number K911462  
Product Classification Trocar - Product Code DRC
Product Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
Code Information Lots 149460 and 149911
Recalling Firm/
Manufacturer		 CooperSurgical, Inc. D.B.A. Lone Star Medical Products
11211 Cash Rd
Stafford TX 77477-4310
For Additional Information Contact Customer Service
203-601-9818
Manufacturer Reason
for Recall		 CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.
FDA Determined
Cause 2		 Error in labeling
Action CooperSurgical sent an Urgent Field Safety Notice ( Correction ) dated September 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm provided correct package inserts (IFU) to affected consignees. The recalling firm intends to conduct effectiveness checks by reviewing return receipts from the initial recall communication. We apologize for any inconvenience this communication may cause. If you have any questions or concerns, please contact CooperSurgical at (203) 601-9818.
Quantity in Commerce 90 units
Distribution Worldwide Distribution: US (nationwide) to North Carolina; and Internationally to Australia and Italy.
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 = DRC and Original Applicant = APPLIED MEDICAL
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