Reported Sep 18, 2013 · Terminated

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

B. Braun Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: B. Braun Medical, Inc. · 901 Marcon Boulevard · Allentown, PA · 18109-9512

Is this the product you have?

  • Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Lot codes and dates
    • Catelog Number 375038
    • Lot Number 0061317318
  • Expiration Date04/30/2016
Amount recalled
900

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 3, 2014 · Data as of Sep 19, 6:16 PM UTC

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