Recall Z-0328-2011 ยท FPO Stretcher, Wheeled
Stryker Medical Div. of Stryker Corporation
Stryker M1 Ambulance cot, Model 6100, Stryker Medical, Kalamazoo, MI.
| Date | Nov 8, 2010 (initiated May 15, 2010) |
| Status | Terminated |
| Reason | The firm has received 42 complaints regarding the head end lock rod, head end slide tube, brushing, and upper cross tube failures. |
| Root cause | Device Design |
| 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 th |
| Quantity | 7,314 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.