FDA Enforcement
Class II
Terminated
Milex Arcing Diaphragm Size 95; Model Number: MXWS95
Recall: Z-1054-2016
·
Reported March 16, 2016
Enforcement
- Recall Number
- Z-1054-2016
- Event ID
- 73329
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- CooperSurgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 16, 2016
- Initiation Date
- February 16, 2016
- Classification Date
- March 4, 2016
- Termination Date
- March 29, 2016
- Address
- 75 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States
Description
Milex Arcing Diaphragm Size 95; Model Number: MXWS95
Reason
The products have been identified to contain an incorrect size Diaphragm.
Code Info
Lot# 130438
Distribution
US Distribution to the states of : OR and NY
Quantity
2 units