Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0765-2023Class II

Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package...

Medical Action Industries, Inc. 306 / initiated 2022-10-12 / Terminated

Medical Action Industries, Inc. 306 began a recall of Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile on . FDA classified it as Class II and gives the reason as "Scissors contained debris". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0765-2023
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medical Action Industries, Inc. 306
Product
Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.
Product code
KDC Instrument, Surgical, Disposable
Reason for recall
Scissors contained debris.
FDA root cause
Under Investigation by firm
Action
The recalling firm issued letters dated 10/12/2022 via email on 10/12/2022. The letter identified the affected product, the reason for recall, and requested the consignee review their inventory and segregate and quarantine all affected product. If any of the product is found, the consignee is to discard it. If the product was further distributed, the consignee is to ensure all end users are appropriately notified of the field correction. A Field Action response Form was to be completed and returned via email as soon as possible to indicate they have read and understand the recall instructions, checked their stock and reported the quantity of product on hand, and notified their appropriate staff of any customers of the notification.
Quantity in commerce
145 cases (240 scissors/case)
Distribution
Distribution was made to FL, IL, IN, MA, MD, MO, OH, and VA. There was no foreign/government/military distribution.
Product codes and lots
Lot #297668, UDI 10809160003473.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0765-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0765-2023Class IITerminatedVoluntary: Firm initiated