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, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
- Recall number
- Z-2175-2013
- 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, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
- Status
- Terminated
- Initiated
- 2012-12-05
- Posted
- 2013-09-10
- Terminated
- 2014-10-24
- Reason
- B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. This could have led to a delay in therapy, or to delivery of an over or under-dose of a therapy if the user was to rely on
- Root cause
- Component design/selection
- Action
- The firm, B. Braun Medical Inc., sent an "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter dated December 05, 2012 to its customers. The letter describes the product, problem and actions taken. The firm finished performing "field upgrades" on March 20, 2010 for this issue. Should you require any additional information, please do not hesitate to contact B. Braun Medical Inc., Infusion Systems Customer Service at 1-800-627-7867 (627-PUMP).
- Quantity
- 14,161
- Distribution
- Worldwide Disribution: USA (nationwide) and country of: Canada.
- Lot, serial or model codes
- Models 620-100 and 620-200; multiple serial numbers
- 510(k) numbers
- ["K994375"]
- 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
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