8713051U recall
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Why was 8713051U recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 9771
- Distribution
- Domestic distribution nationwide. Foreign distribution to Canada.
- Recall date
- November 1, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)