Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottles are used to collect waste f
FDA device recall Z-1554-2009 · posted 2009-07-15 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 905-590 (D512): 35,552 bottles; 905-802 (D513): 45,204 bottles
- Distribution
- Worldwide Distribution to US and Canada.
- Date initiated
- 2009-04-16
- Date posted
- 2009-07-15
- Date terminated
- 2012-05-09
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL800 FLEX (K041874) | Radiometer Medical Aps | 2004-10-08 |
| ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) (K002290) | Radiometer Medical A/S | 2000-09-13 |