Recall Z-1389-2018— Stryker Medical Division of Stryker Corporation

Name: FDA recall Z-1389-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-12

Class II · Terminated

Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2018-03-12, terminated 2020-05-12. It names one FDA 510(k) clearance: K113598. Product: 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.. Reason: The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken..

Recalling firm: Stryker Medical Division of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-03-12
Terminated: 2020-05-12
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K113598 — POWER-LOAD COT FASTENER SYSTEMStryker Medical·cleared 2011-12-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.