FDAFDA · Food and drugs·Recall number Z-0018-2014
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Published October 23, 2013 · Recall initiated: July 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Getinge Disinfection
- Distributor
- USA Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and internationally in Canada.
- Lot
- Model # 46-4, Serial # range SEV0521184-SEV0838137
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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