Stryker Prime Fifth Wheel Stretcher distributed to residential customers instead of healthcare facilities
A medical stretcher designed for healthcare professionals was distributed to residential customers. The device labeling is appropriate for healthcare settings, but home users may not understand or follow the professional-use instructions.
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 recall with no reported injuries or illnesses. The hazard is theoretical risk due to improper use environment (home use instead of healthcare facilities), but no actual harm has been reported. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Medical Division is recalling 3 units of the Prime Fifth Wheel Stretcher, Model 1105 (Part Numbers 1105000026 and 1105000000X). These devices are intended for use in healthcare facilities, but were distributed to residential customers and may be in home use.
The devices' labeling accurately describes the correct use environment and includes instructions intended for healthcare professionals. However, residential customers may not be aware of or fully understand these professional-use instructions. The devices have been distributed worldwide, including throughout the United States and to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand.
The recalled product
- Product
- Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Hazard
- improper-use-environment
- user-training-gap
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#) 07613327278149 07613327278149 07613327278194
Distribution
Distributed nationwide across the United States.
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