Z-1554-2009

Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottles are used to...

Name: Z-1554-2009 Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottles are used to...
Creator: Radiometer America Inc
Published: 2009-04-16
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2009-04-16 / Terminated / root cause: manufacturing process

FDA source

Radiometer America Inc began a recall of 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... on 2009-04-16. The reason FDA records is "When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1554-2009
Status: Terminated
Initiated: 2009-04-16
Posted: 2009-07-15
Terminated: 2012-05-09
Recalling firm: Radiometer America, Inc
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.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.
Root cause tag: manufacturing process
FDA 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 in commerce: 905-590 (D512): 35,552 bottles; 905-802 (D513): 45,204 bottles
Distribution: Worldwide Distribution to US and Canada.
Product codes and lots: 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.

Product code CHL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)