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Stryker Medical Division of Stryker Corporation recalls Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-ter
Recalled August 18, 2021 · FDA recall Z-2208-2021 · Stryker Medical Division of Stryker
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 · FDA Class II
Units
1 unit
Sold at
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Description
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
Product
Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030
Manufacturer(s)
Stryker Medical Division of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →