FDA recall Z-2111-2018

CareFusion 303, Inc. · Class II · device

Product

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

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

Key facts

Status
Terminated
Initiation date
2017-11-06
Report date
2018-06-13
Termination date
2020-12-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2111-2018