FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
- Recall number
- Z-2489-2019
- Recalling firm
- B. Braun Medical, Inc.
- Product
- B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
- Status
- Terminated
- Initiated
- 2019-05-01
- Posted
- 2019-09-23
- Terminated
- 2020-07-13
- Reason
- Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
- Root cause
- Other
- Action
- Urgent Medical Device - Recall Notification letters dated 4/30/19 were sent to customers.
- Quantity
- 2580
- Distribution
- Distribution to US state of TX, and Canada.
- Lot, serial or model codes
- Lot Number 0061641410
- 510(k) numbers
- ["K142036"]
- PMA numbers
- not on file
- Product code
- FPA
- 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