Outlook ES pump is intended for use with B. Braun recall
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…
Why was Outlook ES pump is intended for use with B. Braun recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES with main processor software versions prior to 151580. Multiple serial numbers affected. Affected serial numbers were notified of this field correction.
- 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…
- Recalling firm
- B Braun Medical, Inc.
- Quantity
- 1,970 pumps added for this expansion
- Distribution
- Nationwide Distribution.
- Recall date
- September 18, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)