Skip to content
Recall Observatory FDA recall evidence

Device product

Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to do or be unable to do Model Number: 1460, Part #1460000000¿¿¿¿¿¿¿

Z-2209-2021

May 12, 2021

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 88199
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-2209-2021

Official wording

Reason: 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

Code information: Serial Numbers: 1911040132 1911040133 UDI: 07613327282665

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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