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U.S. Department of Health and Human Services

Class 2 Device Recall CooperSurgical

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  Class 2 Device Recall CooperSurgical see related information
Date Initiated by Firm October 27, 2014
Date Posted December 02, 2014
Recall Status1 Terminated 3 on May 29, 2015
Recall Number Z-0484-2015
Recall Event ID 69636
510(K)Number K905747  
Product Classification Electrocautery, gynecologic (and accessories) - Product Code HGI
Product CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5
Model Number(s): R2010
Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
Code Information Lot 159621 Exp Date: 2017-05
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Vista Pl
Trumbull CT 06611-3934
For Additional Information Contact
203-601-5200
Manufacturer Reason
for Recall		 Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
FDA Determined
Cause 2		 Packaging process control
Action CooperSurgical issued recall letter dated October 27, 2014, to all affected customers via certified mail delivery (UPS). Acccounts were requested to return product for replacement and complete the return response form. Customers with questions were instructed to call 203-601-5200.
Quantity in Commerce 595 units
Distribution Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.
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 = HGI and Original Applicant = COOPERVISION SURGICAL
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