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Devices
Device Recall Portable Oxygen Conserving Regulator.
Model / Serial
Unit S/Ns beginning with ''DHE0010xxxxx'' and ''DHE001100001'' thru ''DHE001102881''
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
The device was distributed nationwide and into China and Japan.
Product Description
Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline label.
Manufacturer
Western a Scott Fetzer Co
3 Events
Recall of Device Recall Portable Oxygen Conserving Regulator.
Recall of Device Recall Portable Oxygen Conserving Regulator.
Recall of Device Recall Portable Oxygen Conserving Regulator.
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Manufacturer
Western a Scott Fetzer Co
Manufacturer Address
Western a Scott Fetzer Co, 875 Bassett Rd, Westlake OH 44145
Source
USFDA
Language
English
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한국어