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Medical Action Industries Inc. Disposable Instrument Pack… recallZ-0765-2023 · Medical Action Industries, Inc. 306 · initiated Oct 12, 2022

Class II Terminated All recalls posted in December 2022

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medical Action Industries, Inc. 306 or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Scissors contained debris.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0765-2023
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 12, 2022
Posted by the FDA
Dec 22, 2022
Recalling firm
Medical Action Industries, Inc. 306
Quantity
145 cases (240 scissors/case)
Product code
KDC
Distribution
Distribution was made to FL, IL, IN, MA, MD, MO, OH, and VA. There was no foreign/government/military distribution.

Product description

Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.

Code information (models, lots, serial numbers)

Lot #297668, UDI 10809160003473.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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