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
Check against the official notice below — it lists the full affected range.
Stryker Corporation is recalling the Prime Big Wheel Stretcher because one unit intended for use only in healthcare facilities was distributed to a residential customer. The stretcher's labeling correctly identifies it for professional healthcare use, but home users may not be aware of or fully understand the instructions designed for healthcare professionals.
The affected stretcher has been distributed worldwide, including throughout the US and in Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. The specific unit involved has the UDI (DI#): 07613327278330. The recall record 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: 1 unit Lot/code info: UDI (DI#): 07613327278330
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.