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