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U.S. Department of Health and Human Services

Class 3 Device Recall CooperSurgical

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  Class 3 Device Recall CooperSurgical see related information
Date Initiated by Firm September 01, 2015
Date Posted October 06, 2015
Recall Status1 Terminated 3 on January 29, 2016
Recall Number Z-0105-2016
Recall Event ID 72107
510(K)Number K910253  
Product Classification Set, anesthesia, paracervical - Product Code HEE
Product CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure
P/N 6061
Code Information LOT 187889
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact SAME
203-601-5200
Manufacturer Reason
for Recall		 Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
FDA Determined
Cause 2		 Labeling Change Control
Action CooperSurgical issued an "Recall Notification" dated September 1, 2015, to all affected customers via FedEX with confirmed delivery receipt. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers asked to discontinue use of affected products and complete the attached Acknowledgement and Receipt Form for a free replacement. Contact Product Surveillance at 203.601.5200 ext. 3300
Quantity in Commerce 305 units
Distribution US Distribution to the states of : AL, AZ, CA, GA, IA, IL, KS, LA, MA, MD, MN, MO, MS, NY, OH, PA, TN, TX, VA, and VT.
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 = HEE and Original Applicant = COOPERSURGICAL, INC.
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