Z-2111-2018 Class II Terminated

Recalled by CareFusion 303, Inc. — San Diego, CA

Recall Details

Product Type
Devices
Report Date
June 13, 2018
Initiation Date
November 6, 2017
Termination Date
December 7, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25,400 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

US Distribution to states of: CA, IL, IN, KS, NE, NJ, TX, UT, VA and WA

Code Information

Model 20022 Lot Numbers 16087775, Model 20022 Lot Numbers 16127995 and Model 30914 Lot Numbers 16127518 and 17097167