FDAClass IIOctober 16, 2024

Aligned Medical Tonsil ENT Pack recall

Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

Why was Aligned Medical Tonsil ENT Pack recalled?

Due to convenience kits containing a kit component that is under a recall action for improper use.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number: AMS9977 UDI-DI code: B098AMS99770 Lot Numbers: 158265 164363 167626 169363 173648 178341 186343 192237 193165 194502 196521 201447 202990 205757 208807 210226 211594 212449

Product
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
894 kits
Distribution
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
Recall date
October 16, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls