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
Check against the official notice below — it lists the full affected range.
Stryker Corporation has recalled 3 units of the Prime Fifth Wheel Stretcher, Model 1105 (Part Numbers 1105000026), distributed worldwide including throughout the US and to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. The stretcher was intended for use only in healthcare facilities, but was mistakenly distributed to residential customers who may be using it in home environments. While the product's labeling correctly identifies its intended use in healthcare settings, home users may not be aware of or fully understand these instructions.
The recall was issued because home users may lack the professional training and facility environment necessary for the device's safe use. The record does not specify a remedy or required action for consumers who may have received this product.
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: 3 units Lot/code info: UDI (DI#) 07613327278149 07613327278149 07613327278194
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.