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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Event Detail

Event ID 64510
Product Type Devices
Status Ongoing
Recalling Firm Cooper Surgical, Inc.
City Trumbull
State CT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-26
Initial Firm Notification of
Consignee or Public
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception. Lot 113367 Class II Incorrect size was printed on the outer product packaging. 80 individual diaphragms Z-1018-2013