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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 Device Recall Diaphragm (contraceptive device) see related information
Date Initiated by Firm February 26, 2013
Date Posted March 28, 2013
Recall Status1 Terminated 3 on March 04, 2014
Recall Number Z-1018-2013
Recall Event ID 64510
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 CT 06611-1350
For Additional Information Contact
203-601-9825
Manufacturer Reason
for Recall		 Incorrect size was printed on the outer product packaging.
FDA Determined
Cause 2		 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 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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