Skip to content
Recall Observatory FDA recall evidence

Device product

Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.

Z-1018-2013

February 26, 2013

Class II

Product summary

Firm
Cooper Surgical, Inc.
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

    reason.no_named_rule · v1.0.0

    Incorrect size was printed on the outer product packaging.