RecallRadar

FDA Device recall Z-2457-2021

BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696

On 2021-09-22 the FDA classified a Class II recall of BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696 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

AgencyFDA Device
Recall numberZ-2457-2021
ClassificationClass II
Statusongoing
Initiated2021-08-02
Published2021-09-22
Last updated2026-09-13 11:56 UTC
CompanyCarefusion
DistributionUS

Product

BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703;

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_infoLots: 20026497 20025590 20076421 21015406 21015407

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-2457-2021%22

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