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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 CooperSurgicalsee related information
Date Initiated by FirmSeptember 01, 2015
Date PostedOctober 06, 2015
Recall Status1 Terminated 3 on January 29, 2016
Recall NumberZ-0105-2016
Recall Event ID 72107
510(K)NumberK910253 
Product Classification Set, anesthesia, paracervical - Product Code HEE
ProductCooperSurgical 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 ContactSAME
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
ActionCooperSurgical 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 Commerce305 units
DistributionUS 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 CycleTPLC 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) Database510(K)s with Product Code = HEE
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