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U.S. Department of Health and Human Services

Class 2 Device Recall TAMPA CATHETER 5 French 33 cm.

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 Class 2 Recall
TAMPA CATHETER 5 French 33 cm.
see related information
Date Posted June 11, 2014
Recall Status1 Open
Recall Number Z-1782-2014
Recall Event ID 68317
Premarket Notification
510(K) Number
K970492 
Product Classification Cannula, Manipulator/Injector, Uterine - Product Code LKF
Product Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Code Information Lot 141525
Recalling Firm/
Manufacturer
CooperSurgical, Inc.
75 Vista Pl
Trumbull, Connecticut 06611-3934
Manufacturer Reason
for Recall
Sterility of the device may be compromised due to unsealed pouch
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Cooper Surgical Inc notified consignees by letter dated 5/13/14 sent via Federal Express with confirmed delivery receipt. Consignees are requested to return for refund or exchange. If you have any further questions contact the firm at 203.601.5200.
Quantity in Commerce 1180 units
Distribution Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LKF and Original Applicant = ACKRAD LABORATORIES
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