CLASS II Device recall · Reported 31 Oct 2018 · FDA Enforcement Report

Altrix¿ Precision Temperature Management System recalled

Stryker Medical Division of Stryker is recalling Altrix¿ Precision Temperature Management System, distributed nationwide in the US. The recall was initiated on 6 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel numbers/ UDI: 8001000001 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 Numbers: US: 201612000100044 201612000100034 201612000100126 201612000100127 201612000100129 201612000100134 201612000100136 201612000100003 201612000100004 201612000100005 201612000100007 201612000100009 201612000100111 201612000100112 201702000100045 201702000100101 201702000100102 201702000100103 201702000100104 201702000100108 201702000100110 201703000100074 201702000100116 201701000100142 201702000100051 201702000100105 201612000100106 Serial Numbers: OUS 201609000500040 201609000500041 201609000500042 201609000500043 201701000500049 201701000500050 201611000100095 201611000100094 201611000100096 201611000100097 201611000100126 201611000100098 201611000100118 201611000100119 201611000100120 201611000100121 201611000100122 201611000100123 201611000100124 201611000100125 201611000100127 201611000100137 201611000100138 201611000100139 201611000100140 201611000100141 201609000500005 201609000500001 201609000500002 201609000500003 201609000500004 201609000500006 201609000500007 201609000500008 201609000500009 201609000500010 201609000500011 201609000500012 201609000500013 201609000500039 201609000500050 201610000500062 201610000500066 201610000500067 201610000500075 201609000500014 201611000500053 201611000500091 201611000500097 201611000500098 201611000500099 201611000500100 201611000500062 201611000500055 201611000500056 201611000500057 201611000500060 201611000500061 201611000500093 201611000500063 201611000500096 201610000500072 201610000500063 201610000500073 201610000500074 201703000500001 201703000500003 201703000500004 201703000500021 201703000500025 201703000500027 201610000500069 201610000500070 201610000500076 Serial Numbers: Stryker Owned 201612000100116 201612000100118 201612000100122 201701000100006 201701000100101 201701000100120 201612000100024 201701000100123 201612000100117 201612000100119 201612000100121 201612000100137 201612000100138 201612000100002 201612000100123 201612000100124 201701000100139 201612000100101 201612000100130 201701000100080 201701000100081 201701000100146 201701000100129 201701000100143 201701000100125 201701000100087 201701000100117 201612000100120 201701000100082 201701000100096 201701000100114 201701000100097 201701000100098 201701000100106 201701000100109 201701000100112 201701000100116 201701000100118 201701000100092 201701000100088 201701000100001 201701000100002 201701000100005 201701000100007 201701000100010 201701000100022 201701000100023 201701000100103 201701000100105 201702000100107 201702000100120 201612000100135 201701000100078 201702000100042 201702000100048 201702000100043 201702000100117 201702000100054 201702000100063 201702000100083 201702000100066 201702000100081 201702000100115 201702000100118 201703000100078 201703000100079 201702000100119 201702000100065 201702000100074 201702000100082 201702000100056 201702000100085 201702000100078 201702000100084 201611000500054 201612000100033 201703000100072 201703000100080 201704000400002 201701000100124 201701000100121 201701000100111 201702000100046 201703000100077 201702000100079

Quantity recalled389 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0235-2019
FDA event ID: 81103
Recalling firm: Stryker Medical Division of Stryker, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 6 Sep 2018
FDA classified: 23 Oct 2018
Reported: 31 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

6 Sep 2018	Recall initiated by company
23 Oct 2018	Classified by FDA	+47 days
31 Oct 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The 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.

Where it was distributed

Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model numbers/ UDI: 8001000001 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 Numbers: US: 201612000100044 201612000100034 201612000100126 201612000100127 201612000100129 201612000100134 201612000100136 201612000100003 201612000100004 201612000100005 201612000100007 201612000100009 201612000100111 201612000100112 201702000100045 201702000100101 201702000100102 201702000100103 201702000100104 201702000100108 201702000100110 201703000100074 201702000100116 201701000100142 201702000100051 201702000100105 201612000100106 Serial Numbers: OUS 201609000500040 201609000500041 201609000500042 201609000500043 201701000500049 201701000500050 201611000100095 201611000100094 201611000100096 201611000100097 201611000100126 201611000100098 201611000100118 201611000100119 201611000100120 201611000100121 201611000100122 201611000100123 201611000100124 201611000100125 201611000100127 201611000100137 201611000100138 201611000100139 201611000100140 201611000100141 201609000500005 201609000500001 201609000500002 201609000500003 201609000500004 201609000500006 201609000500007 201609000500008 201609000500009 201609000500010 201609000500011 201609000500012 201609000500013 201609000500039 201609000500050 201610000500062 201610000500066 201610000500067 201610000500075 201609000500014 201611000500053 201611000500091 201611000500097 201611000500098 201611000500099 201611000500100 201611000500062 201611000500055 201611000500056 201611000500057 201611000500060 201611000500061 201611000500093 201611000500063 201611000500096 201610000500072 201610000500063 201610000500073 201610000500074 201703000500001 201703000500003 201703000500004 201703000500021 201703000500025 201703000500027 201610000500069 201610000500070 201610000500076 Serial Numbers: Stryker Owned 201612000100116 201612000100118 201612000100122 201701000100006 201701000100101 201701000100120 201612000100024 201701000100123 201612000100117 201612000100119 201612000100121 201612000100137 201612000100138 201612000100002 201612000100123 201612000100124 201701000100139 201612000100101 201612000100130 201701000100080 201701000100081 201701000100146 201701000100129 201701000100143 201701000100125 201701000100087 201701000100117 201612000100120 201701000100082 201701000100096 201701000100114 201701000100097 201701000100098 201701000100106 201701000100109 201701000100112 201701000100116 201701000100118 201701000100092 201701000100088 201701000100001 201701000100002 201701000100005 201701000100007 201701000100010 201701000100022 201701000100023 201701000100103 201701000100105 201702000100107 201702000100120 201612000100135 201701000100078 201702000100042 201702000100048 201702000100043 201702000100117 201702000100054 201702000100063 201702000100083 201702000100066 201702000100081 201702000100115 201702000100118 201703000100078 201703000100079 201702000100119 201702000100065 201702000100074 201702000100082 201702000100056 201702000100085 201702000100078 201702000100084 201611000500054 201612000100033 201703000100072 201703000100080 201704000400002 201701000100124 201701000100121 201701000100111 201702000100046 201703000100077 201702000100079

Where was it sold?

Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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