FDAClass IISeptember 18, 2013

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?

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

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?

Multiple serial numbers affected. Model number: 621-100ES, 621-200ES, 621-300ES, and 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…
Recalling firm
B Braun Medical, Inc.
Quantity
28,427
Distribution
Nationwide Distribution.
Recall date
September 18, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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