BD Extension Set SMALLBORE Tubing SmartSite VALVE — Class II medical device recall Z-2460-2021
Ongoing recall by CAREFUSION, reported 2021-09-22, distributed nationwide. Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi
| Recall number | Z-2460-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CAREFUSION, San Diego, CA, United States |
| Recall initiated | 2021-08-02 |
| Classified | 2021-09-13 |
| Reported by FDA | 2021-09-22 |
| Distributed | Nationwide (US) |
| Quantity | 20,874,700 |
| Reason classes | device malfunction |
| Lot numbers | 20015128, 20015129, 20015130, 20015131, 20015132, 20015133, 20015134, 20015143, 20015144, 20015145, 20015146, 20015147, 20015148, 20015149, 20015157, 20015228, 20015229, 20015230, 20015231, 20015257, 20015258, 20015259, 20015260, 20015261, 20015291, 20015292, 20015293, 20015294, 20015295, 20015296, 20015297, 20015298, 20015299, 20015300, 20015301, 20015302, 20015303, 20015389, 20015487, 20015488 and 460 more |
| Model numbers | 10010511, 10010912, 10010983, 10011087, 10011253, 10013902, 10014692, 10015488, 2000E, 20021E, 20035E, 20037E, 20038E, 20039E, 20057E, 20059E, 20061E, 20062E, 20159E, 20338E, 21059E, 22003E-07, 22005E-07T, 22059E, C25015E and 1 more |
Product
BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010983; BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10011087; BD EXTENSION SET SMALLBORE TUBING SmartSite VALVE (DETACHABLE), REF: 10011253; BD EXTENSION SET LOW SORBING TUBING 0.2 MICRON FILTER SmartSite VALVE, REF: 10013902; BD EXTENSION SET 2 SmartSite VALVES Y-CONNECTOR, REF: 10014692; BD EXTENSION SET SMALLBORE TUBING 2 DETACHABLE SmartSite VALVES, REF: 10015488; BD SmartSite NEEDLE FREE VALVE, REF: 2000E; BD Extension Set J-LOOP SMALLBORE Tubing SmartSite VALVE, REF: 20021E; BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 20035E; BD Extension Set SMALLBORE Tubing SmartSite VALVE SLIP LUER, REF: 20037E; BD Extension Set TRI-PORT SMALLBORE Tubing 3 SmartSite VALVES, REF: 20038E; BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 20039E; BD Extension Set SmartSite VALVE SLIP LUER, REF: 20057E; BD Extension Set SmartSite VALVE, REF: 20059E; BD extension Set Y-CONNECTOR 2 SmartSite VALVES, REF: 20061E; BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite VALVES, REF: 20062E; BD EXTENSION SET Y-CONNECTOR 2 SmartSite VALVE, REF: 20159E; BD Extension Set TRI-PORT SMALLBORE TUBING SmartSite VALVE DETACHABLE, REF: 20338E; BD EXTENSION SET SmartSite VALVE, REF: 21059E; BD 8.5-IN PRESSURE RATED EXTENSION SET SmartSite VALVE, REF: 22003E-07; BD Texium SmartSite VALVE MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T; BD EXTENSION SET SmartSite VALVE (DETACHABLE), REF: 22059E; BD EXTENSION SET SmartSite VALVE (DETACHABLE) SLIP LUER, REF: C25015E; BD SmartSite Syringe-Syringe Transfer Device, REF: MV0450
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2460-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.