Outlook ES pump is intended for use with B — Class II medical device recall Z-2175-2013
Terminated recall by B Braun Medical, Inc., reported 2013-09-18, distributed nationwide. B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the los
| Recall number | Z-2175-2013 |
|---|---|
| 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 | 2012-12-05 |
| Classified | 2013-09-10 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2014-10-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 14,161 |
| Model numbers | 620-100, 620-200, 621-100ES, 621-200ES |
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.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2175-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.