Recall Z-0852-2015— Getinge Disinfection Ab
Class II · Terminated
Class II FDA medical device recall by Getinge Disinfection Ab, initiated 2014-11-26, terminated 2017-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.. Reason: Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has identified the problem as insufficient water flow throughout the manifold due to formation of air pockets where sedimentation may occur..
- Recalling firm
- Getinge Disinfection Ab
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-26
- Terminated
- 2017-05-12
- Firm location
- Vaxjo, Sweden
Product description
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Reason for recall
Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has identified the problem as insufficient water flow throughout the manifold due to formation of air pockets where sedimentation may occur.
Data sourced from openFDA. This site is unofficial and independent of the FDA.