Recall Z-1554-2009 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing.
| Date | Jul 15, 2009 (initiated Apr 16, 2009) |
| Status | Terminated |
| Reason | When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle. |
| Root cause | Process design |
| Action | Radiometer America Inc. issued a recall notification letter dated May 5, 2009 to all customers containing information on replacement of all potentially defective waste containers and instruction on how to handle any mounted waste containers. For further questions, contact Radiometer America Inc. at 1-800-736-0600. |
| Quantity | 905-590 (D512): 35,552 bottles; 905-802 (D513): 45,204 bottles |
| Distribution | Worldwide Distribution to US and Canada. |
| FDA record | Open on fda.gov |