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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Radiometer America Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Radiometer America Inc is recalling Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottles are us due to When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026