Reported Nov 30, 2022 · Ongoing
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart…
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.
- Lot codes and dates
- Model Number4000
- Product Codes4000-0106-00
- and 4000-0106-01 UDI501951706962; Serial #'s
394 of 394 codes
203384420338452033846203385020338512033852203385420338562033857203385820338592033861203386220338642033865203386620338672033871203387520338772033878203388020339822033984203410420341062034107203410820341092034110203411320341152034116203411720341182034120203412320341242034125203412620341292034131203413220341332034134203413520341362034137203413820341392034140203414120341422034143203414420341452034146203414720341482034149
- UDI501951707075; Serial #'s
2028673204403720209172032957203747720400702041392204152720416682049487200668520067172006750200858220086202047401204902220499272049932204993420499412060111206040520604412061199206796220679772067988
- Amount recalled
- 422 devices
Where it was sold
Why it was recalled
Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
This product could cause temporary or reversible health problems — stop using it.
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