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Devices
Device Recall Decomat
Model / Serial
Serial numbers 81972 through 82063; and SEV0141098 through SEV0304112.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide. Medical facilities in AL, CA, CO, LA, MA, MI, MN, MO, NC, NH, NM, OK, PA, TX, WA, and WI.
Product Description
Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.
Manufacturer
Getinge/Castle, Inc.
1 Event
Recall of Device Recall Decomat
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Manufacturer
Getinge/Castle, Inc.
Manufacturer Address
Getinge/Castle, Inc., 1777 E Henrietta Road, Rochester NY 14623
Source
USFDA
Language
English
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