FDAFDA · Food and drugs·Recall number Z-1018-2013
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Published April 3, 2013 · Recall initiated: February 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect size was printed on the outer product packaging.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cooper Surgical, Inc.
- Distributor
- 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.
- Lot
- Lot 113367
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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