Medical device recalls Moderate risk

ICU Medical, Inc. recalls 113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroC…

Recall date
April 20, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1591-2015
FDA classification
Class II
Brand / firm
ICU Medical, Inc.
Sold / distributed
Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN

Why it was recalled

ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

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

What was recalled

113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP Tubing, Item No. B33303 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

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