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Terminated

Stryker M1 Ambulance cot, Model 6100, Stryker Medical, Kalamazoo, MI.

FDA Recall Z-0328-2011 · Posted 2010-11-08

Recalling FirmStryker Medical Div. of Stryker Corporation
Recall StatusTerminated
Product CodeFPO
Date Initiated2010-05-15
Date Terminated2012-02-07
Product Quantity7,314

Reason for Recall

The firm has received 42 complaints regarding the head end lock rod, head end slide tube, brushing, and upper cross tube failures.

Firm Action

Stryker Medical sent an Urgent Medical Device Alert letter dated May 15, 2010 to all customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter stated that there is a possibility for fatigue related failures of certain components of the cot and that a Stryker representative will visit the firm to correct the device. A representative from Stryker field service would contact the customer to perform the device corrections, free of charge. Immediate Action required by the customer: Locate the ambulance cots listed in this notice. Return the enclosed post card to confirm receipt of this notification. If any of the cots listed in the letter were loaned or sold the customer was to forward a copy of the notice to the new users and advise Stryker of their new location. If the customer disposed of any of the affected stretchers and they were no longer in use, customers were to advise Stryker of their obsolescence by providing the serial numbers For any questions or comments regarding this issue, please call (800) 869-0770, ext. 6902.

Root Cause

Device Design

Distribution Pattern

Worldlwide Distribution - US including AZ, CA, CO, FL, LA, MS, NC, NJ, OH, PA, and TN and the countries of Australia, China, France, Germany, Hong Kong, Italy, Japan, New South Wales, Poland, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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