Reported Aug 8, 2012 · Terminated
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers…
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. · 1265 Grey Fox Rd · Saint Paul, MN · 55112-6929
Is this the product you have?
- Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
- Lot codes and dates
- 2004542, and 2004550.
605 of 605 codes
200024520002462000247200024820002492000250200025120002522000253200025420002552000256200025720002582000259200026020002612000262200026320002642000265200026620002672000268200026920002702000271200027220002732000274200027520002762000277200027820002792000280200028120002822000283200028420002852000286200028720002882000289200029020002912000292200029320002942000295200029620002972000298200029920003002000301200030220003032000304
- Amount recalled
- 607 pumps (257 USA, 350 Canada)
Where it was sold
Why it was recalled
Stop using this product now
Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation.
Using this product could cause serious injury, illness or death — stop using it now.
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