FDA-Device2021-08-18Class II

InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿

Stryker Medical Division of Stryker Corporation
Hazard

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Sold states
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Affected count
2 units
Manufactured in
3800 E Centre Ave, N/A, Portage, MI, United States
Products
InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2210-2021

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