FDA Enforcement
Class II
Terminated
ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
Recall: Z-1367-2019
·
Reported May 29, 2019
Enforcement
- Recall Number
- Z-1367-2019
- Event ID
- 82663
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- CooperSurgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 29, 2019
- Initiation Date
- March 27, 2019
- Classification Date
- May 17, 2019
- Termination Date
- May 1, 2020
- Address
- 95 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States
Description
ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
Reason
ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent
Code Info
Lot 1557
Distribution
Foreign: Denmark, Italy, Sweden
Quantity
480 units