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U.S. Department of Health and Human Services

Class 2 Device Recall Diaphragm (contraceptive device)

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 Class 2 Recall
Diaphragm (contraceptive device)
see related information
Date Posted March 28, 2013
Recall Status1 Terminated on March 04, 2014
Recall Number Z-1018-2013
Recall Event ID 64510
Premarket Notification
510(K) Number
K063223 
Product Classification Diaphragm, Contraceptive (And Accessories) - Product Code HDW
Product Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Code Information Lot 113367
Recalling Firm/
Manufacturer
Cooper Surgical, Inc.
75 Corporate Dr
Trumbull, Connecticut 06611-1350
Manufacturer Reason
for Recall
Incorrect size was printed on the outer product packaging.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action CSI notified consignees affected by this recall by a Recall Notification letter, dated February 26, 2013, sent via Federal Express with confirmed delivery receipt. The letter identified the affected product, and asked customers to contact the firm's Customer Service Department at 1-800-243-2974, if they had any of the affected lot in their inventory. Customers also have the option of completing the form attached to the letter and faxing it back to 800-262-0105. At CooperSurgical's expense, arrangements will made to replace the affected products that customers have on hand. The firm will provide further instruction and disposition of the product at the time of replacement.
Quantity in Commerce 80 individual diaphragms
Distribution Worldwide Distribution -- USA, including the states of NE, MA, FL, TN, CA, ME, SC, CA, NH, OK, TX, NM, MO, NY, PA, and AZ, and countries of Germany, Italy, and 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 = HDW and Original Applicant = COOPERSURGICAL, INC.
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