CAREFUSION recalls specific SmartSite Bag Access Devices with needle-free valves that may cause flow issues or occlusions, potentially delaying therapy. Affected units include model REF: 2300E and REF: 2309E-0006 with listed lot numbers.
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.
CAREFUSION is recalling SmartSite Bag Access Devices with needle-free valves that may cause flow problems or blockages, which could delay medical therapy. This recall affects specific model numbers and lot ranges sold between 2006 and 2011.
The needle-free valves in these devices can become partially or fully blocked, causing flow issues that might delay medical treatment. However, the recall states that follow-up activation is not needed if the device has already been used or was safely connected to a female luer.
Healthcare providers using these devices for medical therapy are most at risk. Patients receiving treatment with the recalled devices may experience delayed therapy if the valve becomes blocked.
Check for model numbers REF: 2300E or REF: 2309E-0006 on the device. Affected units were sold with specific lot numbers listed in the recall notice between 2006 and 2011.
Identify if your device has model numbers REF: 2300E or REF: 2309E-0006.
No, the recall does not require immediate stop use. The device can be used if it has already been safely connected to a female luer.
The valve may cause flow issues or partial/full blockages, which could delay therapy. However, follow-up activation is not required if the device has been used or safely connected.
Check for model numbers REF: 2300E or REF: 2309E-0006 and lot numbers listed in the recall notice (20066502 through 21036466).
We’ve drafted a message you can send CAREFUSION to request your refund or repair — edit it as you like.
Subject: Recall Z-2468-2021 — CAREFUSION CAREFUSION Hello, I own a CAREFUSION that is covered by recall Z-2468-2021 from CAREFUSION. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
