FDA Medical Device Recalls (openFDA)
B Braun Medical, Inc.: Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
- Recall number
- Z-2164-2013
- Recalling firm
- B Braun Medical, Inc.
- Product
- Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
- Status
- Terminated
- Initiated
- 2012-10-31
- Posted
- 2013-09-06
- Terminated
- 2016-02-03
- Reason
- This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This occurs when a sequence of HOLD - HOLD key strokes are performed on the pump key panel while the user is in the Dose Dat
- Root cause
- Software design
- Action
- The firm decided to conduct a field correction to correct the issue and carried it out through routine field services. The firm was notified by FDA that this is a reportable event, so they notified their consignees via letters dated 10/31/2012.
- Quantity
- 1,970 pumps added for this expansion
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES with main processor software versions prior to 151580. Multiple serial numbers affected. Affected serial numbers were notified of this field correction.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1641965
- Firm city
- Carrollton
- Firm state
- TX
- 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
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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