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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

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

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 Letter
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.