FDA-Device2022-10-26Class II
ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
B. Braun Medical, Inc.
Hazard
The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.
Sold states
Distribution US nationwide, Canada and Saudi Arabia.
Affected count
354,200 US; 1,800 OUS
Manufactured in
901 Marcon Blvd, N/A, Allentown, PA, United States
Products
ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0090-2023Don't want to check this manually?
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