Medical device recalls Moderate risk

US Infusion Inc dba Trucare Biomedix-USA recalls Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.

Recall date
October 10, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1277-2015
FDA classification
Class II
Brand / firm
US Infusion Inc dba Trucare Biomedix-USA
Sold / distributed
Distributed in the states of TX, IL, MA, OH, CA, and GA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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