Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2166-2013

August 05, 2013

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 65993
Status
Terminated
Classification
Class II
Quantity
900
Official record key
device-enforcement:Z-2166-2013

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.