BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP… — Class II medical device recall Z-2462-2021
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-2462-2021 |
|---|---|
| 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 | 29,130 |
| Reason classes | device malfunction |
| Lot numbers | 20026597, 20026598, 20096477, 20106218, 20115237, 20126022, 20126023 |
| Model numbers | 10012564 |
Product
BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564
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-2462-2021. 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.