Outlook ES pump is intended for use with B — Class II medical device recall Z-2163-2013
Terminated recall by B Braun Medical, Inc., reported 2013-09-18, distributed nationwide. B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel m
| Recall number | Z-2163-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B Braun Medical, Inc., Carrollton, TX, United States |
| Recall initiated | 2012-10-24 |
| Classified | 2013-09-06 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2015-07-27 |
| Distributed | Nationwide (US) |
| Quantity | 28,427 |
| Reason classes | device malfunction |
| Model numbers | 621-100ES, 621-200ES, 621-300ES, 621-400ES |
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 for recall
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.