Recall Z-1013-2012 ยท FPO Stretcher, Wheeled
Cardiopulmonary Instrumentation, Inc
CI healthcare***Model: CI8092***S/N: 5-60-85-044 MFD: JUN, 2010 MADE IN CHINA***cihealthcare.com This stainless steel stretcher is used for transporting patients.
| Date | Feb 14, 2012 (initiated Feb 17, 2011) |
| Status | Terminated |
| Reason | Cardiopulmonary Instrumentation, Inc. dba CI Healthcare, Miami, FL, is recalling their Stainless Steel Patient Transport Stretcher, model # CI-8092, Lot 002, because of a malfunction that occurs when weight is applied to the backrest. This malfunction causes the backrest support bar, when secured in the first hook, to fall to a flat position. |
| Root cause | Device Design |
| Action | CI Healthcare sent an "URGENT RECALL NOTIFICATION" letter dated February 17, 2011, to its customer. The letter describes the product, problem and actions to be taken. The customer were instructed to do the following: 1) Examine their inventory and isolate the product(s). 2) If they have distributed any of the products to other services or facilities, please forward this information as appropriate. 3) Discontinue use of the product until a correction has been properly executed and 4) Complete and return the "Recall Response Form" as soon as possible. Should you have any questions, please call |
| Quantity | 72 Units |
| Distribution | Nationwide Distribution - to one distributor in Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.