Data Foundry

Medical device recalls 2018

Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is… — Class II medical device recall Z-2111-2018

Terminated recall by CareFusion 303, Inc., reported 2018-06-13, distributed in CA, IL, IN, KS, NE, NJ, TX, UT…. Reports of incorrect priming volume due to manufacturing with incorrect tubing.

Recall numberZ-2111-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCareFusion 303, Inc., San Diego, CA, United States
Recall initiated2017-11-06
Classified2018-06-07
Reported by FDA2018-06-13
Terminated2020-12-07
DistributedCA, IL, IN, KS, NE, NJ, TX, UT, VA, WA
Quantity25,400 units
Lot numbers16087775, 16127518, 16127995, 17097167
Model numbers20022, 30914

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2111-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.