Medfusion Syringe Pump Models: 3500 — Class I medical device recall Z-1272-2022
Ongoing recall by Smiths Medical ASD Inc., reported 2022-06-29, distributed nationwide. Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA
| Recall number | Z-1272-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2022-04-18 |
| Classified | 2022-06-21 |
| Reported by FDA | 2022-06-29 |
| Distributed | Nationwide (US) |
| Quantity | 65,093 units |
| UPC / GTIN / UDI-DI | 00061058603001, 00061058603117, 00061058604329 |
| NDC | 03500-0600-00, 03500-0600-01, 03500-0600-50, 03500-0600-51, 03500-0600-82 |
| Serial numbers | 02405, 038373, 038409, 038410, 038411, 038412, 038413, 038414, 038415, 046361, 046362, 048866, 048867, 050259, 050943, 050944, 050945, 050946, 050947, 050958, 050959, 050960, 050961, 050962, 050963 and 475 more |
| Model numbers | 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE |
Product
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, Software Versions 6.0.0, 6.0.1
Reason for recall
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001
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-1272-2022. 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.