Reported Jul 20, 2022 · Terminated
Ivenix Infusion System (IIS)
Ivenix, 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: Ivenix, Inc. · 50 High St Ste 50 · North Andover, MA · 01845-2620
Is this the product you have?
- Ivenix Infusion System (IIS)
- Lot codes and dates
- UDI-DILVP-SW-0004 Software version 5.0
- System serial numbers
1,335 of 1,335 codes
211820001121193004112119300414211930041521193004172119300418211930042121193004222119300423211930042421193004252119300426211930042721193004282119300429211930043021193004312119300432211930043421193004352119300436211930043721193004382119300439211930044021193004412119300442212430005021243000512124300052212430005521243000582124300062212430006721243000682124300070212430007321243000742124300076212430007821243000792124300081212430008221243000842124300086212430008721243000882124300089212430009021243000922124300094212430009521243000962124300101212430010221243001052124300123212430012421243001272124300133
- Amount recalled
- 1335 devices
Where it was sold
Why it was recalled
Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
This product could cause temporary or reversible health problems — stop using it.
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