CAREFUSION recalls BD SmartSite Bag Access Device and Check Valve models with potential flow issues that could delay therapy. Affected units include specific lot numbers from 20025450 to 20106710.
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 two types of SmartSite Bag Access Devices due to possible flow problems that might delay medical therapy. This could affect patients using these devices for treatments like dialysis.
The needle-free connector valves may have difficulty flushing or causing partial or total blockages, which could delay medical therapy. However, the product does not require follow-up activation if it has already been used or safely connected.
Patients using these devices for medical treatments like dialysis are most at risk. The recall affects specific lot numbers produced between 20025450 and 20106710.
Check for lot numbers listed in the recall: 20025450 through 20106710. The product names are BD SmartSite Bag Access Device (REF: 2300E-0500) and BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE (REF: 2309E).
Look for the lot number on the device, which should be one of the listed numbers from 20025450 to 20106710.
No, the recall does not require immediate stop use. The product can be safely used if it has already been used or was properly connected.
Check the lot number on your device. If it matches the listed numbers, contact CAREFUSION for further instructions.
The affected devices have lot numbers from 20025450 to 20106710. Check the product name and lot number on your device.
We’ve drafted a message you can send CAREFUSION to request your refund or repair — edit it as you like.
Subject: Recall Z-2461-2021 — CAREFUSION CAREFUSION Hello, I own a CAREFUSION that is covered by recall Z-2461-2021 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.
