Reported Oct 31, 2018 · Terminated
Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating…
Stryker Medical Division of Stryker Corporation
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: Stryker Medical Division of Stryker Corporation · 3800 E Centre Ave · Portage, MI · 49002-5826
Is this the product you have?
- Altrix¿ Precision
- Temperature Management System Model8001Product
- UsageThe Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician or clinician with prescription privileges determines that temperature therapy is necessary or desirable
- Lot codes and dates
- Model numbers/ UDI8001000001 07613327277555; 8001000003 07613327277562; 8001000008 07613327277630; 8001000015 07613327277722; 8001000016 07613327277586; 8001000017 07613327277609; 8001000018 07613327277678; 8001000019 07613327277623; 8001000023 07613327277777 Altrix model 8001 units manufactured between October 4, 2016 and June 30, 2017:
- Serial NumbersUS:
201612000100044201612000100034201612000100126201612000100127201612000100129201612000100134201612000100136201612000100003201612000100004201612000100005201612000100007201612000100009201612000100111201612000100112201702000100045201702000100101201702000100102201702000100103201702000100104201702000100108201702000100110201703000100074201702000100116201701000100142201702000100051201702000100105201612000100106
- Serial NumbersOUS
74 of 74 codes
201609000500040201609000500041201609000500042201609000500043201701000500049201701000500050201611000100095201611000100094201611000100096201611000100097201611000100126201611000100098201611000100118201611000100119201611000100120201611000100121201611000100122201611000100123201611000100124201611000100125201611000100127201611000100137201611000100138201611000100139201611000100140201611000100141201609000500005201609000500001201609000500002201609000500003201609000500004201609000500006201609000500007201609000500008201609000500009201609000500010201609000500011201609000500012201609000500013201609000500039201609000500050201610000500062201610000500066201610000500067201610000500075201609000500014201611000500053201611000500091201611000500097201611000500098201611000500099201611000500100201611000500062201611000500055201611000500056201611000500057201611000500060201611000500061201611000500093201611000500063
- Serial NumbersStryker Owned
85 of 85 codes
201612000100116201612000100118201612000100122201701000100006201701000100101201701000100120201612000100024201701000100123201612000100117201612000100119201612000100121201612000100137201612000100138201612000100002201612000100123201612000100124201701000100139201612000100101201612000100130201701000100080201701000100081201701000100146201701000100129201701000100143201701000100125201701000100087201701000100117201612000100120201701000100082201701000100096201701000100114201701000100097201701000100098201701000100106201701000100109201701000100112201701000100116201701000100118201701000100092201701000100088201701000100001201701000100002201701000100005201701000100007201701000100010201701000100022201701000100023201701000100103201701000100105201702000100107201702000100120201612000100135201701000100078201702000100042201702000100048201702000100043201702000100117201702000100054201702000100063201702000100083
- Amount recalled
- 389 units
Where it was sold
- Nationwide
Why it was recalled
Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5¿C while in Automatic mode. 2. Users may experience a Remove from Use code 9 (RFU 9) fault condition relating to inadvertent flow alarms.3. Users may experience code RFU 27 fault condition relating to mechanical interference between the device fan and filter
This product could cause temporary or reversible health problems — stop using it.
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