FDAClass IIAugust 18, 2021

Prime TC-transport chair intended for medical purposes recall: Labeling Error

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…

Why was Prime TC-transport chair intended for medical purposes 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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: 1911040132 1911040133 UDI: 07613327282665

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…
Recalling firm
Stryker Medical Division of Stryker Corporation
Quantity
2 units
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Recall date
August 18, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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