FDA Device recall Z-2163-2013
Outlook ES pump is intended for use with B. Braun Medical Inc
- FDA Device
- Class II
- terminated
- Published 2013-09-18
On 2013-09-18 the FDA classified a Class II recall of Outlook ES pump is intended for use with B. Braun Medical Inc by B Braun Medical, citing B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel may fail to function as intended if the underlying circuitry fails due….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2163-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-24 |
| Published | 2013-09-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | B Braun Medical |
| Distribution | US |
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.
Reason
B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel may fail to function as intended if the underlying circuitry fails due to intermittent contact. This issue applies specifically to the HOLD button. If this occurs, the Door Processor (DP) will not receive the desired input from the user. This issue can be observed in pumps with key panels
Identifiers
| code_info | Multiple serial numbers affected. Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2163-2013%22
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