Z-0029-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2024
- Initiation Date
- August 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 packs
Product Description
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.
Reason for Recall
Due to convenience kits containing a kit component that is under a recall action for improper use.
Distribution Pattern
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
Code Information
Catalog Number: AMS11480 UDI-DI code: B098AMS114800 Lot Numbers: 205273