FDA-Device2013-04-03Class II
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Cooper Surgical, Inc.
Hazard
Incorrect size was printed on the outer product packaging.
Sold states
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.
Affected count
80 individual diaphragms
Manufactured in
75 Corporate Dr, Trumbull, CT, United States
Products
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1018-2013Don't want to check this manually?
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