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U.S. Department of Health and Human Services

Class 2 Device Recall Milex Arcing Diaphragm

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  Class 2 Device Recall Milex Arcing Diaphragm see related information
Date Initiated by Firm February 16, 2016
Date Posted March 04, 2016
Recall Status1 Terminated 3 on March 29, 2016
Recall Number Z-1054-2016
Recall Event ID 73329
510(K)Number K063223  
Product Classification Diaphragm, contraceptive (and accessories) - Product Code HDW
Product Milex Arcing Diaphragm Size 95; Model Number: MXWS95
Code Information Lot# 130438
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact
203-601-9818
Manufacturer Reason
for Recall		 The products have been identified to contain an incorrect size Diaphragm.
FDA Determined
Cause 2		 Package design/selection
Action Cooper Surgical sent an "Urgent - Medical Device Recall" letter dated February 16, 2016, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer. Customers were instructed to discontinue use of the affected products and complete the attached Acknowledgement and Receipt form for replacement. For further questions, please call (203) 601-9818.
Quantity in Commerce 2 units
Distribution US Distribution to the states of : OR and NY
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 = HDW and Original Applicant = COOPERSURGICAL, INC.
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