Reported Dec 31, 2014 · Terminated
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer ---…
Getinge Disinfection Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Getinge Disinfection Ab · Ljungadalsgatan 11 · Vaxjo · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Numbers
546 of 546 codes
SEV0810077SEV0537108SEV0633084W50030454SEV0724143SEV0724146SEV0609110W50044787SEV0533068W50042461W50023731W50023732W50038744W50028760SEV0802081W50015468W50042473W50045852W50048201W50041156SEV0911139SEV0832021W50031347SEV0538174SEV0910190SEV0734181W50033518SEV0802083W50043877W50015494W50047828SEV0633086SEV0647025SEV0650003SEV0650004SEV0534069SEV0617130W50011492SEV0538177W50010176W50027826SEV0743108W50012356SEV0614021W50039525SEV0619121W50021052W50025573W50024233W50010768SEV0827061SEV0738121SEV0804079SEV0806117SEV0820063SEV0820064W50041988SEV0727015SEV0739202SEV0906031
- SEV0802082 --- Canadian Units
SEV0538175SEV0613101W50030182W50030412
- Serial Numbers
- Amount recalled
- 551 total: USA: 547 units, Canada: 4 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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