ClearanceBrief
Recall Z-1935-2020 ยท INK Stretcher, Wheeled, Powered

Stryker Medical Division of Stryker Corporation

Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).

DateApr 7, 2020
StatusTerminated
ReasonAmbulance Cots may not meet crash test standard BS EN 1789
Root causeComponent change control
ActionStryker issued Initial notification to International distribution partners via electronic notification system on 4/7/20. Customers will be notified by written letter distributed via traceable methods. Letter states reason for recall, health risk and action to take: 1. Locate the units listed on the attached business reply form and identify the address where they can be serviced. 2. Return the enclosed business reply form to confirm receipt of this notification by fax or email 269 488 8691 or email productfieldaction@stryker.com the enclosed acknowledgement of this notification. Power-PRO" TL c
Quantity34 units
DistributionForeign: UK
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.