Recall Z-1814-2015— CooperSurgical, Inc.
Class II · Terminated
Class II FDA medical device recall by CooperSurgical, Inc., initiated 2015-05-20, terminated 2016-01-20. It names one FDA 510(k) clearance: K063223. Product: MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80. Reason: A diaphragm size 80 labeled box was incorrectly packaged with a size 85..
- Recalling firm
- CooperSurgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-20
- Terminated
- 2016-01-20
- 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
MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
Reason for recall
A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
Data sourced from openFDA. This site is unofficial and independent of the FDA.