PlainRecalls
FDA Devices Moderate Class II Ongoing

Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿

Reported: August 18, 2021 Initiated: May 12, 2021 #Z-2219-2021

Product Description

Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿

Reason for Recall

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

Details

Units Affected
1 unit
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Location
Portage, MI

Frequently Asked Questions

What product was recalled?
Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿. Recalled by Stryker Medical Division of Stryker Corporation. Units affected: 1 unit.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on August 18, 2021. Severity: Moderate. Recall number: Z-2219-2021.