CAREFUSION recalls BD Extension Set Smallbore Tubing with 2 SmartSite Valves (REF: 20019E) due to potential flow issues and occlusions that may delay therapy. Affected units include specific lots listed in the 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.
CAREFUSION is recalling BD Extension Set Smallbore Tubing with 2 SmartSite Valves (REF: 20019E) because the needle-free connector valves may cause flow problems or blockages, leading to therapy delays. This affects patients using medical infusion systems who rely on these components.
The SmartSite valves in the tubing may cause difficulty flushing, flow issues, or partial or total blockages. This can lead to therapy delays but does not typically cause immediate injury or require emergency action.
Patients using medical infusion systems with the recalled tubing sets are affected. Those with chronic conditions requiring frequent infusions are at higher risk due to potential therapy delays.
Check for the product name 'BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES' and the lot numbers listed in the recall (e.g., 21045673, 21045672, etc.). The reference number is 20019E.
Identify the product by checking the lot numbers listed in the recall (e.g., 21045673, 21045672) and the reference number 20019E.
No, the recall does not require immediate discontinuation. The product may be used safely if it has already been connected to the female luer of a connecting device.
The recall does not specify a remedy, so no action is required beyond checking if your product matches the listed lot numbers.
The recall states that the product may cause therapy delays but does not mention risks of serious injury or death.
We’ve drafted a message you can send CAREFUSION to request your refund or repair — edit it as you like.
Subject: Recall Z-2454-2021 — CAREFUSION CAREFUSION Hello, I own a CAREFUSION that is covered by recall Z-2454-2021 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.
