CAREFUSION BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006
Brand
CAREFUSION
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lots: 20066405 20075901 20075902 20076376 20076377 20116469 21016457 21016458 21016459 21016460 21016690 21016691 21035305 21035306 21035418 21035419 21035420 21035421 21035422 21035423 21035424
CAREFUSION is recalling BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006 due to Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 08/02/21, Urgent Medical Device Correction notices were mailed and emailed to consignees who were asked to notify recalling firm if this issue was experienced at 1-844-823-5433, productcomplaints@bd.com . Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device. If during priming the clinician encounters an occluded needle-free connector, take the following actions: 1) Depress the syringe plunger while the syringe is still attached to the needle-free connector. 2) If unable to depress the plunger, pull back on the syringe plunger and depress the syringe plunger again. Repeating this step may assist in opening the needle-free connector valve. 3) If the valve still is not open; without disconnecting the syringe male luer tip from the BD SmartSite valve surface, carefully unthread and rethread the syringe to partially disengage and reengage the syringe. Repeating this step up to three times may assist in opening the needle-free valve. Note: To maintain sterility, do not allow the syringe and needle-free valve to completely disconnect. 4) If previous steps do not open the valve, then open a new needle-free connector to replace the occluded connector. 5) After the steps above, proceed with the existing instructions for use. 6) Share this correction notification with all users within your facility network of the product to ensure they are also aware of this correction. 7) Complete and return the Customer Response Form. Distributors were asked to identify customers within their distribution network that purchased the affected product and to email an excel file listing of all customers to the recalling firm within 72 hours of receipt of this letter so the recalling firm can initiate customer notification. See online tool to support the identification of impacted lot numbers https://www.bd.com/MDS-21-4144
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026