Reported Oct 16, 2024 · Ongoing

Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a…

Windstone Medical Packaging, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Windstone Medical Packaging, Inc. · 1602 4th Ave N · Billings, MT · 59101-1521

Is this the product you have?

  • 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 codes and dates
  • Catalog NumberAMS11480
  • UDI-DI codeB098AMS114800
  • Lot Numbers205273
Amount recalled
60 packs

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.