Reported Jun 29, 2022 · Ongoing
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51,…
Smiths Medical ASD Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- Medfusion Syringe Pump Models
35003500-0600-003500-0600-013500-0600-2493500-0600-503500-0600-513500-0600-823500-3063500-4023500-4143500-4153500-5003500BC3500E3500G3500SD3500SD-5003500VX3500VX-3063500VX-4143500VX-4153500VX-5003500ZESoftware Versions 6.0.06.0.1
- Lot codes and dates
- Model 3500No UDI
- Serial NumbersModel 3500: No UDI
- Serial Numbers
4,066 of 4,066 codes
M63658M36749M16998M31819M62715M62716M29795M21251M32302M31248M31839M29543M22299M34554M29749M22179M25875M21234M28137M31041M29706M23786M62354M23774M23778M24318M31709M62633M29883M20907M32080M24983M30672M30681M31390M31714M62349M63113M34559M63122M31838M41492M29612M63639M27898M41481M22427M21834M33123M62589M27729M21711M25684M25667M23784M24070M24474M41485M25890M32006
- Amount recalled
- 65093 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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