FDA-Device2021-08-18Class II
Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
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
3 units
Manufactured in
3800 E Centre Ave, N/A, Portage, MI, United States
Products
Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2207-2021Don't want to check this manually?
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