FDA Device recall Z-2463-2021
BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07
- FDA Device
- Class II
- ongoing
- Published 2021-09-22
On 2021-09-22 the FDA classified a Class II recall of BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07 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-2463-2021 |
| 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 Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK 4 Smartsite VALVES & SmartSite EXT SET, REF: 42407E-05
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: 20025968 20026013 20035834 20035835 20026132 20026133 20085151 |
|---|
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-2463-2021%22
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