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¿¿¿¿¿¿¿
Check against the official notice below — it lists the full affected range.
Stryker Corporation's Prime TC-transport chair, a medical device designed for use in healthcare facilities, was distributed to residential customers who may be using it in home environments. Although the product's labeling correctly identifies that it is intended for healthcare facility use, home users may not be aware of or fully understand the instructions written for healthcare professionals.
A total of 2 units with serial numbers 1911040132 and 1911040133 were distributed worldwide, including across the United States and to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand. Quantity: 2 units Lot/code info: Serial Numbers: 1911040132 1911040133 UDI: 07613327282665
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.