CLASS II Device recall · Reported 18 Sep 2013 · FDA Enforcement Report
Outlook ES pump is intended for use with B recalled by B Braun Medical
B Braun Medical is recalling Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets, distributed nationwide in the US. The recall was initiated on 5 Dec 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2175-2013
- FDA event ID
- 64150
- Recalling firm
- B Braun Medical, Carrollton, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Dec 2012
- FDA classified
- 10 Sep 2013
- Reported
- 18 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Syringes & Needles
Timeline
| 5 Dec 2012 | Recall initiated by company | |
| 10 Sep 2013 | Classified by FDA | +279 days |
| 18 Sep 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Disribution: USA (nationwide) and country of: Canada.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Models 620-100 and 620-200; multiple serial numbers
Where was it sold?
Worldwide Disribution: USA (nationwide) and country of: Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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