Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Catalog Number: AMS14809 UDI-DI code: B098AMS148090 Lot Numbers: 192737 194922 200224 200950 203412
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Windstone Medical Packaging, Inc.
Reason for Recall:
Due to convenience kits containing a kit component that is under a recall action for improper use.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

Product Codes/Lot Numbers:

Catalog Number: AMS14809 UDI-DI code: B098AMS148090 Lot Numbers: 192737 194922 200224 200950 203412

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0031-2025

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The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).

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