IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 110 IN.; Catalog Number: 490566.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    1. Catalog Number: 490566; Primary UDI-DI: 04046955275625; Unit of Dose UDI-DI: 04046955275618; Expiration Date: Earliest Exp of Comp or 36mths.
  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:
B Braun Medical Inc
Reason for Recall:
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability 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:

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 110 IN.; Catalog Number: 490566.

Product Codes/Lot Numbers:

1. Catalog Number: 490566; Primary UDI-DI: 04046955275625; Unit of Dose UDI-DI: 04046955275618; Expiration Date: Earliest Exp of Comp or 36mths.

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0718-2026

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Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

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Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

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Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

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