FDA Device recall Z-2111-2018
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient…
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient… by Carefusion 303, citing reports of incorrect priming volume due to manufacturing with incorrect tubing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2111-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-06 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Carefusion 303 |
| Distribution | CA, IL, IN, KS, NE, NJ, TX, UT, VA, WA |
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
Reports of incorrect priming volume due to manufacturing with incorrect tubing.
Identifiers
| code_info | Model 20022 Lot Numbers 16087775, Model 20022 Lot Numbers 16127995 and Model 30914 Lot Numbers 16127518 and 17097167 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2111-2018%22
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