FDA-Device2018-03-21Class III
T/Pump temperature therapy pump, Models TP700 and TP700C
Stryker Medical Division of Stryker Corporation
Hazard
The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the Indications for Use statement.
Sold states
Distributed in all 50 states, the District of Columbia, and Guam.
Affected count
9902
Manufactured in
3800 E Centre Ave, Portage, MI, United States
Products
T/Pump temperature therapy pump, Models TP700 and TP700C
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1013-2018Don't want to check this manually?
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