Medical device recalls Moderate risk

CareFusion 303, Inc. recalls Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a sy…

Recall date
November 6, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2111-2018
FDA classification
Class II
Brand / firm
CareFusion 303, Inc.
Sold / distributed
US Distribution to states of: CA, IL, IN, KS, NE, NJ, TX, UT, VA and WA

Why it was recalled

Reports of incorrect priming volume due to manufacturing with incorrect tubing.

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

What was recalled

Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components are commonly found on intravascular administration sets and extension sets. It includes a microbore tubing, a slide clamp, male and female luer.

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