Infusomat Space Volumetric Pump Administration Set, Product Code 490100

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Number: 0061761278
  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:
There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Infusomat Space Volumetric Pump Administration Set, Product Code 490100

Product Codes/Lot Numbers:

Lot Number: 0061761278

Distribution:

Distributed in: US, CA, MI, OR, UT

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2137-2021

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