FDAClass IIOctober 16, 2024

Aligned Medical Septo Pack recall

Aligned Medical Septo Pack REF AMS11480 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 Septo 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: AMS11480 UDI-DI code: B098AMS114800 Lot Numbers: 205273

Product
Aligned Medical Septo Pack REF AMS11480 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
60 packs
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