FDA Device recall Z-1272-2022

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, 3500-40…

FDA Device
Class I
ongoing
Published 2022-06-29

On 2022-06-29 the FDA classified a Class I recall of Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-40… 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-1272-2022
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 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

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 3500: No UDI, Serial Numbers: Model 3500: No UDI, Serial Numbers: M63658, M36749, M16998, M31819, M62715, M627… Model 3500: No UDI, Serial Numbers: Model 3500: No UDI, Serial Numbers: M63658, M36749, M16998, M31819, M62715, M62716, M29795, M21251, M32302, M31248, M31839, M29543, M22299, M34554, M29749, M22179, M25875, M21234, M28137, M31041, M29706, M23786, M62354, M23774, M23778, M24318, M31709, M62633, M29883, M20907, M32080, M24983, M30672, M30681, M31390, M31714, M62349, M63113, M34559, M63122, M31838, M41492, M29612, M63639, M27898, M41481, M22427, M21834, M33123, M62589, M27729, M21711, M25684, M25667, M23784, M24070, M24474, M41485, M25890, M32006, M21197, M26866, M21209, M25481, M26336, M26868, M26859, M21233, M22286, M30821, M27632, M21236, M21263, M21265, M21287, M27636, M27655, M28438, M28475, M27821, M23202, M28443, M21268, M24319, M21244, M34586, M21261, M25547, M28101, M21290, M30815, M26467, M34593, M34894, M22888, M26101, M37713, M63645, M62306, M30205, M21681, M22012, M22013, M27635, M21661, M27547, M34197, M27641, M27644, M27656, M27658, M26100, M32056, M23204, M30626, M2239

code_info

Model 3500: No UDI, Serial Numbers: Model 3500: No UDI, Serial Numbers: M63658, M36749, M16998, M31819, M62715, M627…

Model 3500: No UDI, Serial Numbers: Model 3500: No UDI, Serial Numbers: M63658, M36749, M16998, M31819, M62715, M62716, M29795, M21251, M32302, M31248, M31839, M29543, M22299, M34554, M29749, M22179, M25875, M21234, M28137, M31041, M29706, M23786, M62354, M23774, M23778, M24318, M31709, M62633, M29883, M20907, M32080, M24983, M30672, M30681, M31390, M31714, M62349, M63113, M34559, M63122, M31838, M41492, M29612, M63639, M27898, M41481, M22427, M21834, M33123, M62589, M27729, M21711, M25684, M25667, M23784, M24070, M24474, M41485, M25890, M32006, M21197, M26866, M21209, M25481, M26336, M26868, M26859, M21233, M22286, M30821, M27632, M21236, M21263, M21265, M21287, M27636, M27655, M28438, M28475, M27821, M23202, M28443, M21268, M24319, M21244, M34586, M21261, M25547, M28101, M21290, M30815, M26467, M34593, M34894, M22888, M26101, M37713, M63645, M62306, M30205, M21681, M22012, M22013, M27635, M21661, M27547, M34197, M27641, M27644, M27656, M27658, M26100, M32056, M23204, M30626, M2239

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-1272-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.