FDA Device recall Z-2459-2021
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012
- FDA Device
- Class II
- ongoing
- Published 2021-09-22
On 2021-09-22 the FDA classified a Class II recall of BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012 by Carefusion, citing needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2459-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-02 |
| Published | 2021-09-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carefusion |
| Distribution | US |
Product
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Buerette Set SmartSite Port (Burette) 3 SmartSite Y-Sites, REF: 10821753; BD Alaris Pump Infusion Buerette Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 11607787; BD Alaris Pump Infusion Buerette Set 0.2Micron Filter Ball Valve SmartSite Port (Burette) 2 SmartSite Y-Sites, REF: 11613191; BD Alaris Pump Infusion Buerette Set Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2440-0600; BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Site, REF: 2441-0007; BD Alaris Pump Infusion Buerette Set Low Sorbing Tubing Smartsite Port (Burette), REF: 2444-0007; BD Alaris Pump Infusion Buerette Set Ball Valve Smartsite Port (Burette) 2 Smartsite Y-Sites, REF: 2447-0007; BD Alaris Pump Infusion Set Back Check Valve 4-Way Stopcock 3 Smartsite Y-Sites Extension Set With SmartSite Port, REF: C24104E
Reason
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
Identifiers
| code_info | Lots: 20055717 20066810 20066818 20066819 20077318 20077321 20077322 20077522 20077523 20077541 20086584 2…Lots: 20055717 20066810 20066818 20066819 20077318 20077321 20077322 20077522 20077523 20077541 20086584 20106957 20106958 20106959 21025085 21025086 21025220 20025114 20025123 20026226 20026227 20026322 20026323 20026382 20026383 20026510 20056946 20056947 20057055 20057056 20017423 20096285 20096286 20015347 20016918 20016919 20016960 20016961 20017112 20035102 20035133 20035134 20035281 20035295 20035296 20035368 20035526 20035527 20035603 20035604 20056757 20065191 20065192 20065281 20065282 20065298 20065299 20065346 20065347 20065362 20065759 20065944 20065945 20065946 20075258 20075510 20075511 20075512 20075577 20075643 20075644 20075660 20075719 20075720 20075721 20075887 20075888 20075889 20075890 20076104 20076847 20076848 20076872 20076873 20076874 20076965 20076966 20076967 20076968 20076969 20077074 20077075 20085132 20085133 20085134 20085135 20085697 20085698 20085699 20 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2459-2021%22
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