ClearanceBrief
Recall Z-2184-2010 ยท INK Stretcher, Wheeled, Powered

Stryker Medical Div. of Stryker Corporation

Stryker M-Series Stretcher, Model 1025 (SM304), Stryker Medical, Portage, MI.

DateAug 9, 2010 (initiated Mar 19, 2010)
StatusTerminated
ReasonThe retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.
Root causeComponent design/selection
ActionThe firm has sent Urgent - Medical Device Recall letters, dated March 19, 2010, to all direct accounts notifying them of the recall. The letter identified the affected product and described the reason for recall. Customers were asked to locate the stretchers identified in the letter and visually inspect each cord. If the plug shows signs of excessive wear, etc. the stretcher is to be taken out of service immediately and the plug removed. Customers are to call the number provided in order to be placed on the priority replacement list. If the cord does not show signs of damage then the stre
Quantity4,558 Stretchers
DistributionWorldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K022309STRYKER POWERED WHEELED STRETCHER
Stryker Corp., Nov 8, 2002