Stryker Renaissance Series Stretchers, Model 1731Z PACU with Zoom, Stryker Medical, Portage, MI.

FDA device recall Z-2186-2010 · posted 2010-08-09 · Terminated

Recall details

Recalling firm

Stryker Medical Div. of Stryker Corporation

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.

Action taken

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

Status

Terminated

Product code

INK

Quantity affected

19 Stretchers

Distribution

Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.

Date initiated

2010-03-19

Date posted

2010-08-09

Date terminated

2011-05-02

Location

Portage, MI

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