Z-1018-2013 Class II Terminated
FDA device recall Z-1018-2013 was initiated by Cooper Surgical, Inc. on February 26, 2013 and is designated Class II. Reason for recall: Incorrect size was printed on the outer product packaging. The recall status is terminated (terminated March 4, 2014). Affected quantity: 80 individual diaphragms.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2013
- Initiation Date
- February 26, 2013
- Termination Date
- March 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 individual diaphragms
Product Description
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Reason for Recall
Incorrect size was printed on the outer product packaging.
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.
Code Information
Lot 113367