Recall Z-1018-2013— Cooper Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Cooper Surgical, Inc., initiated 2013-02-26, terminated 2014-03-04. It names one FDA 510(k) clearance: K063223. Product: Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.. Reason: Incorrect size was printed on the outer product packaging..
- Recalling firm
- Cooper Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-26
- Terminated
- 2014-03-04
- Firm location
- Trumbull, CT, United States
510(k) clearances named in this recall
1 on FDA's record- K063223 — MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.