CLASS II Device recall · Reported 18 Sep 2013 · FDA Enforcement Report

Outlook Safety Infusion System Burette Set recalled by B. Braun Medical

B. Braun Medical is recalling Outlook Safety Infusion System Burette Set, distributed in Florida, New Jersey, New York, Texas. The recall was initiated on 5 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatelog Number 375038, Lot Number 0061317318, Expiration Date: 04/30/2016

Quantity recalled900

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-2166-2013
FDA event ID: 65993
Recalling firm: B. Braun Medical, Allentown, PA
Classification: Class II
Status: Terminated
Recall initiated: 5 Aug 2013
FDA classified: 6 Sep 2013
Reported: 18 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Aug 2013	Recall initiated by company
6 Sep 2013	Classified by FDA	+32 days
18 Sep 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

Distributed in the states of FL, NY, NJ, and TX.

Florida New Jersey New York Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Distributed in the states of FL, NY, NJ, and TX.

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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