Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primar
FDA device recall Z-2164-2013 · posted 2013-09-06 · Terminated
Recall details
- Recalling firm
- B Braun Medical, Inc.
- Reason for recall
- This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This occurs when a sequence of HOLD - HOLD key strokes are performed on the pump key panel while the user is in the Dose Dat
- Action taken
- The firm decided to conduct a field correction to correct the issue and carried it out through routine field services. The firm was notified by FDA that this is a reportable event, so they notified their consignees via letters dated 10/31/2012.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 1,970 pumps added for this expansion
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-10-31
- Date posted
- 2013-09-06
- Date terminated
- 2016-02-03
- Location
- Carrollton, TX
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