Device product
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Z-1018-2013
Product summary
- Event
- Event 64510
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 individual diaphragms
- Official record key
device-enforcement:Z-1018-2013
Official wording
Reason: Incorrect size was printed on the outer product packaging.
Code information: Lot 113367
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.
Derived failure modes
-
Unknown
Incorrect size was printed on the outer product packaging.