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Device Recall Smiths Medical FLO2 Emergency Nonrebreather High Flow O2 System
Model / Serial
Lot Numbers: 37L04D188 and 38A030257
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution including USA states of CA, FL, IN, KS, MN, MO, NC, NH, NY, PA and TN, and country of Canada.
Product Description
Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Smiths Medical, Rockland, MA 02370.
Manufacturer
Smiths Medical ASD, Inc.
1 Event
Recall of Device Recall Smiths Medical FLO2 Emergency Nonrebreather High Flow O2 System
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Manufacturer
Smiths Medical ASD, Inc.
Manufacturer Address
Smiths Medical ASD, Inc., 160 Weymouth St, Rockland MA 02370-1136
Source
USFDA
Language
English
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