BD SmartSite — Class II medical device recall Z-2467-2021
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-2467-2021 |
|---|---|
| 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 | 23,786,178 |
| Reason classes | device malfunction |
| Lot numbers | 1015511, 1016651, 1016663, 1016664, 1016761, 1016762, 1017045, 1017152, 1017153, 1017154, 1017306, 1017679, 1017680, 1017681, 1017964, 1018010, 1018316, 1018317, 1018575, 1018576, 1018577, 1018578, 1018579, 1018583, 1018584, 1019392, 1019393, 1019582, 1019583, 1019584, 1019886, 1019892, 1019925, 1020131, 1020967, 1021008, 1021015, 20016252, 20016253, 20016254 and 460 more |
| Model numbers | 2000E, 2000E-04, 2000E7D, 20021E7D, 20037E7D, 20038E7D, 20039E7D, 20059E-0006, 20060E7D, 20061E7D, 20062E7D, 20159E7D, 60103E, 63441E |
Product
BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D; BD SmartSite Extension Set One Needle Free Valve, REF: 20039E7D; BD SmartSite Extension Set 1 Needle-Free Valve, 20049E7D; BD Extension Set 1 Needle-Free Valve, REF: 20059E-0006; BD SmartSite Extension Set 1 Needle-Free Valve, REF: 20060E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20061E7D; BD SmartSite Extension Set Check Valve 3 Needle Free Valves, REF: 20062E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20159E7D; BD Alaris GP Series SmartSite Burette Set, REF: 60103E; BD Alaris GP Series Burette Set No Filter, REF: 63441E; Alaris SmartSite needle-free valve, REF: 2000E7D
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-2467-2021. 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.