8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 04046964660887 Serial Numbers: 868497 -892669 ***Updated 8/7/24*** SNs added: 430056, 430119, 430155, 430243, 551518, 685947, 703196, 705968, 726936, 737729, 753364, 774163, 790843, 814074
- 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:
- B. Braun Medical, Inc.
- Reason for Recall:
- Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Product Codes/Lot Numbers:
UDI-DI: 04046964660887 Serial Numbers: 868497 -892669 ***Updated 8/7/24*** SNs added: 430056, 430119, 430155, 430243, 551518, 685947, 703196, 705968, 726936, 737729, 753364, 774163, 790843, 814074
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0123-2024
Related Recalls
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B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.