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Recall Observatory FDA recall evidence

Device product

Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

Z-0031-2025

August 16, 2024

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 95306
Status
Ongoing
Classification
Class II
Quantity
180 packs
Official record key
device-enforcement:Z-0031-2025

Official wording

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

Code information: Catalog Number: AMS14809 UDI-DI code: B098AMS148090 Lot Numbers: 192737 194922 200224 200950 203412

Distribution pattern: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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