PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: October 16, 2024 Initiated: August 16, 2024 #Z-0028-2025

Product Description

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.

Reason for Recall

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

Details

Units Affected
894 kits
Distribution
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
Location
Billings, MT

Frequently Asked Questions

What product was recalled?
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.. Recalled by Windstone Medical Packaging, Inc.. Units affected: 894 kits.
Why was this product recalled?
Due to convenience kits containing a kit component that is under a recall action for improper use.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 16, 2024. Severity: Moderate. Recall number: Z-0028-2025.