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Recall Observatory FDA recall evidence

Device 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.

Z-0028-2025

August 16, 2024

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 95306
Status
Ongoing
Classification
Class II
Quantity
894 kits
Official record key
device-enforcement:Z-0028-2025

Official wording

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

Code information: Catalog Number: 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

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.