Device product
Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025
Product summary
- Event
- Event 95306
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40 packs
- Official record key
device-enforcement:Z-0030-2025
Official wording
Reason: Due to convenience kits containing a kit component that is under a recall action for improper use.
Code information: Catalog Number: AMS11482 UDI-DI code: B098AMS114820 Lot Numbers: 205275
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.