Reported Apr 6, 2022 · Ongoing
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP,…
InfuTronix LLC
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: InfuTronix LLC · 177 Pine St · Natick, MA · 01760-1331
Is this the product you have?
- Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
- Lot codes and dates
- (UDI): (01)00817170020086
- Lot2009231440
- Serial Numbers
74 of 74 codes
807483807484807485807486807487807489807490807491807492807493807494807495807496807497807498807499807500807502807651807652807653807507807508807509807510807511807512807513807514807515807516807517807518807519807520807521807522807523807524807525807526807527807528807529807530807531807532807533807534807535807536807537807538807539807540807541807542807543807544807545
- Amount recalled
- 74 units
Where it was sold
Why it was recalled
An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.
This product could cause temporary or reversible health problems — stop using it.
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