Prime TC Transport Chair Recalled for Improper Residential Distribution
The Prime TC-transport chair, designed for healthcare facility use, was distributed to residential customers who may not understand the professional-level operating instructions. The recall addresses potential risk of improper use by home users.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a distribution and labeling mismatch where a healthcare-facility device was sent to residential customers. No illnesses, injuries, or deaths have been reported. The hazard is potential improper use if home users do not understand professional-level operating instructions.
Plain-English summary
The Prime TC-transport chair, Model 1460, manufactured by Stryker Medical Division of Stryker Corporation, is being recalled. The device is a medical transport chair intended for use in healthcare facilities to assist patients with mobility and daily activities. Two units were affected, bearing serial numbers 1911040132 and 1911040133.
The devices were improperly distributed to residential customers. While the product labeling correctly identifies the intended use environment as healthcare facilities, home users may not be aware of or fully understand the operating instructions that were designed for healthcare professionals. This distribution error creates a potential risk of improper use by consumers lacking professional healthcare device training.
The affected devices were distributed worldwide, including throughout the United States and to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand.
The recalled product
- 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¿¿¿¿¿¿¿
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Hazard
- improper-use
- labeling-mismatch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: 1911040132 1911040133 UDI: 07613327282665
Distribution
Distributed nationwide across the United States.
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