FDA-Device2024-10-16Class II
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.
Windstone Medical Packaging, Inc.
Hazard
Due to convenience kits containing a kit component that is under a recall action for improper use.
Sold states
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
Affected count
894 kits
Manufactured in
1602 4th Ave N, Billings, MT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0028-2025Don't want to check this manually?
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