FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
- Recall number
- Z-0123-2024
- Recalling firm
- B. Braun Medical, Inc.
- Product
- 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
- Status
- Open, Classified
- Initiated
- 2023-09-21
- Posted
- 2023-10-25
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Component design/selection
- Action
- On September 21, 2023, the firm began notifying customers of the issue via "URGENT MEDICAL DEVICE CORRECTION" letters. BBMI will schedule service to update impacted devices. Customers were provided with stickers to identify affected units while waiting for the service to be completed. In the meantime, customers were informed of measures that may aid in continued use of the pumps, such as only using non-impacted devices for the delivery of high-risk medications and placing the impacted units in care areas that do not administer high risk medications. Customers may contact BBMI by calling 1-800-627-7867 (1-800-627-PUMP) for technical support for potential alternate interim measures. ***Updated 8/7/24*** On August 7, 2024, firm identified additional units which were serviced using potentially impacted sensors. Serial numbers were added to the two models already in scope (Article Numbers 8713051U and 8713052U). Serial numbers from an additional model (Article No. 8713050U) also added and tracked under RES 95093.
- Quantity
- 9771
- Distribution
- Domestic distribution nationwide. Foreign distribution to Canada.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K142596","K191910"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28