FDA Device recall Z-2188-2013
Outlook ES pump is intended for use with B. Braun Medical Inc
- FDA Device
- Class I
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class I recall of Outlook ES pump is intended for use with B. Braun Medical Inc by B Braun Medical, citing this notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on August 26, 2011 due to an issue in which the Outlook ES Safety Infusion Sy….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2188-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-11-14 |
| Published | 2013-09-25 |
| 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: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
Reason
This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on August 26, 2011 due to an issue in which the Outlook ES Safety Infusion System may halt infusion but the "RUN" Light Emitting Diodes (LEDs) on the front display continue to advance as if the pump were infusing. The pump emits a backup alarm, but there are no visual indicators that the infusion
Identifiers
| code_info | Model number: 621-300ES and 621-400ES. Multiple serial numbers affected. |
|---|
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-2188-2013%22
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