FDA Enforcement
Class II
Terminated
Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.
Recall: Z-0765-2023
·
Reported December 28, 2022
Enforcement
- Recall Number
- Z-0765-2023
- Event ID
- 91066
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medical Action Industries, Inc. 306
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 28, 2022
- Initiation Date
- October 12, 2022
- Classification Date
- December 22, 2022
- Termination Date
- February 19, 2025
- Address
- 25 Heywood Rd, Arden, NC, 28704-9302, United States
Description
Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.
Reason
Scissors contained debris.
Code Info
Lot #297668, UDI 10809160003473.
Distribution
Distribution was made to FL, IL, IN, MA, MD, MO, OH, and VA. There was no foreign/government/military distribution.
Quantity
145 cases (240 scissors/case)