Stryker Medical Division of Stryker Corporation recalls Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assi…

Recall date

March 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1389-2018

FDA classification

Class II

Brand / firm

Stryker Medical Division of Stryker Corporation

Sold / distributed

Worldwide Distribution - USA (nationwide) and to the countries of : Australia, Canada, France, Germany, Hong Kong, Italy, India, Netherlands, Portugal, Saint Martin, Switzerland, United Kingdom

Why it was recalled

The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lb (395 kg), which includes the weight of the ambulance cot, patient, and equipment attached to the cot (such as oxygen bottles, monitors, and pumps). The intended users of the device are trained professionals, including emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers.