FDA Device recall Z-1271-2022
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 40…
- FDA Device
- Class I
- ongoing
- Published 2022-06-29
On 2022-06-29 the FDA classified a Class I recall of Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 40… by Smiths Medical Asd, citing 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. I….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1271-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-04-18 |
| Published | 2022-06-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
Product
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
Reason
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
Identifiers
| code_info | Model 4000-0100-50: UDI 061058603532, Serial Numbers: 2000380, 2000342, 2000351, 2000485, 2002080, 2000501, 2000275, 2…Model 4000-0100-50: UDI 061058603532, Serial Numbers: 2000380, 2000342, 2000351, 2000485, 2002080, 2000501, 2000275, 2002089, 2000528, 2000386, 2002086, 2000555, 2002083, 2000530, 2000495, 2002084, 2002087, 2000452, 2002092, 2000489, 2000283, 2002098, 2000309, 2000315, 2000434, 2002094, 2000442, 2000427, 2000334, 2000388, 2000415, 2000270, 2000364, 2000401, 2002103, 2000377, 2000579, 2002101, 2000352, 2002090, 2000474, 2000456, 2002102, 2000307, 2000323, 2000368, 2000337, 2000429, 2000466, 2000296, 2000294, 2000340, 2000457, 2000412, 2000339, 2000543, 2000470, 2000319, 2000399, 2000539, 2002095, 2000404, 2000384, 2000250, 2000328, 2002097, 2000564, 2000266, 2000350, 2000446, 2000372, 2000569, 2000289, 2000344, 2000253, 2000416, 2000259, 2000367, 2000293, 2000418, 2000422, 2000459, 2000463, 2000435, 2000335, 2000295, 2000562, 2000394, 2000407, 2000510, 2000373, 2000249, 2000292, 2000301, 2000557, 2000303, 2000378, 2000327, 2000538, 2000263, 2000410, 2000420, 2000424, 2000514, 2000536, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1271-2022%22
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