Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- 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).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Product Codes/Lot Numbers:
UDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1921-2026
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Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Windstone Medical Packaging
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).
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.
Windstone Medical Packaging
Due to convenience kits containing a kit component that is under a recall action for improper use.