FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
- Recall number
- Z-2166-2013
- Recalling firm
- B. Braun Medical, Inc.
- Product
- Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
- Status
- Terminated
- Initiated
- 2013-08-05
- Posted
- 2013-09-06
- Terminated
- 2014-09-03
- Reason
- Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve was assembled upside down.
- Root cause
- Process control
- Action
- On August 4, 2013, a letter was sent to direct accounts asking them to check their inventory for the affected product. These customers were also instructed to notify their customers if the product was further distributed and to return all affected product and/or the product removal acknowledgement form.
- Quantity
- 900
- Distribution
- Distributed in the states of FL, NY, NJ, and TX.
- Lot, serial or model codes
- Catelog Number 375038, Lot Number 0061317318, Expiration Date: 04/30/2016
- 510(k) numbers
- ["K904518","K921860","K955585"]
- 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