FDA Enforcement
Class II
Terminated
Sterile Nail Clipper Concave Edge (67710)
Recall: Z-1719-2019
·
Reported June 12, 2019
Enforcement
- Recall Number
- Z-1719-2019
- Event ID
- 82667
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Centurion Medical Products Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 12, 2019
- Initiation Date
- March 29, 2019
- Classification Date
- June 4, 2019
- Termination Date
- May 8, 2020
- Address
- 100 Centurion Way, Williamston, MI, 48895-9086, United States
Description
Sterile Nail Clipper Concave Edge (67710)
Reason
Compromised seal on the sterile barrier pouch.
Code Info
Lot 2018120701, exp 2023-11-30
Distribution
US nationwide distribution.