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Cooper Surgical, Inc. recalls Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contracept
Recalled April 3, 2013 · FDA recall Z-1018-2013 · Cooper Surgical
Hazard
Incorrect size was printed on the outer product packaging. · FDA Class II
Units
80 individual diaphragms
Sold at
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.
Description
Incorrect size was printed on the outer product packaging.
Product
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Manufacturer(s)
Cooper Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →