| Class 3 Device Recall CooperSurgical |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HEE
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