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)