FDA-Device2013-09-18Class II
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
B. Braun Medical, Inc.
Hazard
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.
Sold states
Distributed in the states of FL, NY, NJ, and TX.
Affected count
900
Manufactured in
901 Marcon Boulevard, N/A, Allentown, PA, United States
Products
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2166-2013Don't want to check this manually?
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