Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a
Summary
The FDA issued a Class II for Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem 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-0029-2025
Action Date
2024-10-16
Status
Ongoing
Category
device
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.
Lot/Code Info: Catalog Number: AMS11480 UDI-DI code: B098AMS114800 Lot Numbers: 205273
Quantity Affected: 60 packs
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-0029-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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