FDA-Device2015-03-25Class II

Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.

US Infusion Inc dba Trucare Biomedix-USA
Hazard

Several complaints regarding the IV sets leaking at the Y site.

Sold states
Distributed in the states of TX, IL, MA, OH, CA, and GA.
Affected count
62,700 IV sets
Manufactured in
6356 Manor Ln, Suite 103, South Miami, FL, United States
Products
Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1277-2015

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