Recall StatusTerminated
Date Initiated2010-03-19
Date Terminated2011-05-02
Product Quantity39 Stretchers
Reason for Recall
The 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.
Firm Action
The 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 stretcher can remain in service until a replacement cord is available. The enclosed post card should be completed and returned to the firm. A copy of the notice should be forwarded to any users that stretchers have been sold or loaned to. The firm should be provided with the serial numbers of any stretchers that have been disposed of. Questions should be directed towards Stryker at 800-STRYKER.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.