Stryker Prime Big Wheel Stretcher distributed to home users may lack professional-only guidance
The Prime Big Wheel Stretcher was distributed to home users, but is intended for professional healthcare facility use only. Home users may not understand the professional-only instructions, creating safety risks.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification indicates moderate risk. The device is designed for professional healthcare use only but was distributed to home users who may not understand professional-only instructions. This creates risk of improper use and potential injury in an unsupervised home setting, though no illnesses or injuries have been reported.
Plain-English summary
Stryker Medical Division of Stryker Corporation identified an issue with the Prime Big Wheel Stretcher (Model 1115, Part Number 1115000030). The device is intended for use in healthcare facilities for short-term clinical evaluation, treatment, minor procedures, and recovery. Its labeling correctly identifies these professional-only requirements.
However, the stretcher was distributed worldwide, including to residential customers in the United States and in Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. Home users may not be aware of or fully understand that this device requires professional healthcare facility use, as the instructions are written for trained healthcare professionals.
Consumers with this device should review the labeling to confirm they understand its professional-only use requirements. The product is not designed for unsupervised use in home environments.
The recalled product
- Product
- Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Hazard
- improper-use
- fall-injury
- insufficient-training
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)
- UDI (DI#): 07613327278330
Distribution
Distributed nationwide across the United States.
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