Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged
Summary
The FDA issued a Class II for Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Sa by Windstone Medical Packaging, Inc.. Reason: Due to convenience kits containing a kit component that is under a recall action for improper use..
Details
Source
Device Recall
External ID
Z-0028-2025
Action Date
2024-10-16
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 894 kits
Reason for Recall
Due to convenience kits containing a kit component that is under a recall action for improper use.
Distribution
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-16
Company
Billings, MT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 123 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Windstone Medical Packaging, Inc. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Windstone Medical Packaging, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Windstone Medical Packaging, Inc. have FDA actions?
Windstone Medical Packaging, Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0028-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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