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.
This recall has been terminated (originally issued July 15, 2009).
- Company
- Radiometer America Inc
- Recall Initiated
- April 16, 2009
- Posted
- July 15, 2009
- Terminated
- May 9, 2012
- Recall Number
- Z-1554-2009
- Quantity
- 905-590 (D512): 35,552 bottles; 905-802 (D513): 45,204 bottles
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Reason for Recall
When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.
Distribution
Worldwide Distribution to US and Canada.
Lot / Code Info
Part Number: 905-590; Article Number: D512; Lot Numbers: WR-01, WR-02, WR-03, WS-01, WS-02, WS-03, WU-01, WU-02 and WU-03. Part Number 905-802; Article Number: D513; Lot Numbers: WR-01, WR-02, WR-03, WR-04, WS-01, WS-02, WS-03, WS-04, WU-01, WU-02, WU-03, WU-04, WU-05, WU-06 and WY-01.
Root Cause
Process design
Action Taken
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.