ClearanceBrief
Recall Z-0739-2017 ยท FPO Stretcher, Wheeled

Stryker Medical Division of Stryker Corporation

Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled

DateNov 8, 2016
StatusTerminated
ReasonStryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD and bounced back during loading which could cause injury to consumers.
Root causeUnder Investigation by firm
ActionStryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners MODEL: 6392, due to complaints and service reports that some cots compatible with the Performance-LOAD cot fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD (bounced back during loading) which could lead to injury of consumers. Customer notification letters were sent via Fedex on November 8, 2016. Customers were asked to quarantine the impacted devices and submit completed business reply forms by fax (269)488-8691 or email productfieldaction@stryke
Quantity749 units
DistributionWorldwide Distribution to AK, AL , AR , AZ , CA , CT , DC , DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA , RI, SC, TN, TX, UT,VA, VT ,WA ,WV ,WY and Internationally to Canada and the Netherlands
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.