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U.S. Department of Health and Human Services

Class 2 Device Recall CooperSurgical H/S Catheter

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  Class 2 Device Recall CooperSurgical H/S Catheter see related information
Date Initiated by Firm July 03, 2014
Date Posted September 05, 2014
Recall Status1 Terminated 3 on May 28, 2015
Recall Number Z-2570-2014
Recall Event ID 68754
510(K)Number K020951  
Product Classification Cannula, manipulator/injector, uterine - Product Code LKF
Product CooperSurgical H/S CATHETER (PART # 61-5007)

Intended for Hysterosonography/ Hysterosalpingography.
Code Information Lot 153914
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Vista Pl
Trumbull CT 06611-3934
For Additional Information Contact
203-601-9818
Manufacturer Reason
for Recall		 Unsealed pouches.
FDA Determined
Cause 2		 Packaging process control
Action Customer notification letter was sent on July 1, 2014 via UPS with confirmed delivery receipt. The letter identified the product, the problem, and the action needed to be taken by the customer. At CooperSurgical's expense, arrangements were made to replace any of the affected products that customers may have on hand. For questions contact James Keller, Vice President, Regulatory Affairs/Quality Assurance at 203-601-5200.
Quantity in Commerce 1,400 units
Distribution Worldwide Distribution -- USA, in the states of CA, TX, IL, MI, MS, ID, NY, FL, MD, PA, OR, GA, CO, WA, NJ, HI, and NC, including DC; and the countries of the countries of Spain, England, Holland, and United Kingdom.
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 = LKF and Original Applicant = ACKRAD LABORATORIES
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