FDA Device recall Z-2464-2021
BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006
- FDA Device
- Class II
- ongoing
- Published 2021-09-22
On 2021-09-22 the FDA classified a Class II recall of BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006 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-2464-2021 |
| 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 ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006
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: 20066405 20075901 20075902 20076376 20076377 20116469 21016457 21016458 21016459 21016460 21016690 2…Lots: 20066405 20075901 20075902 20076376 20076377 20116469 21016457 21016458 21016459 21016460 21016690 21016691 21035305 21035306 21035418 21035419 21035420 21035421 21035422 21035423 21035424 |
|---|
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-2464-2021%22
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