FDAClass IISeptember 18, 2013

Outlook Safety Infusion System Burette Set. For recall

Outlook Safety Infusion System Burette Set. For intravenous fluid administration.

Why was Outlook Safety Infusion System Burette Set. For recalled?

Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve was assembled upside down.

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?

Catelog Number 375038, Lot Number 0061317318, Expiration Date: 04/30/2016

Product
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Recalling firm
B. Braun Medical, Inc.
Quantity
900
Distribution
Distributed in the states of FL, NY, NJ, and TX.
Recall date
September 18, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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