Recall Z-2455-2021— CAREFUSION

Name: FDA recall Z-2455-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-02

Class II · Ongoing

Class II FDA medical device recall by CAREFUSION, initiated 2021-08-02. It names one FDA 510(k) clearance: K061285. Product: BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D. 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..

Recalling firm: CAREFUSION
Classification: Class II
Status: Ongoing
Initiated: 2021-08-02
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K061285 — SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETSCardinal Health, Alaris Products·cleared 2006-07-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.