Recall Z-1054-2016— CooperSurgical, Inc.
Class II · Terminated
Class II FDA medical device recall by CooperSurgical, Inc., initiated 2016-02-16, terminated 2016-03-29. It names one FDA 510(k) clearance: K063223. Product: Milex Arcing Diaphragm Size 95; Model Number: MXWS95. Reason: The products have been identified to contain an incorrect size Diaphragm..
- Recalling firm
- CooperSurgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-16
- Terminated
- 2016-03-29
- 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 Arcing Diaphragm Size 95; Model Number: MXWS95
Reason for recall
The products have been identified to contain an incorrect size Diaphragm.
Data sourced from openFDA. This site is unofficial and independent of the FDA.