Class II — B Braun Medical, Inc.
| Recalling firm | B. BRAUN MEDICAL SAS |
|---|---|
| Registered facility | B. BRAUN MEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| 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 … |
| Quantity | 1,970 pumps added for this expansion |
| Distribution | Nationwide Distribution. |
| Initiated | 2012-10-31 |
| Classified | 2013-09-06 |
| Terminated | 2016-02-03 |
| Recall number | Z-2164-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — B Braun Medical, Inc. (Z-2164-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64146/
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