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Devices
Device Recall Infinity Direct Nasal Mask
Model / Serial
Lot numbers for Part Numbers: HC481A (lot #s:050128 to 060506) & HC481SL (lot #s: 050608 to 060327)
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks.
Manufacturer
Fisher & Paykel Healthcare Inc
1 Event
Recall of Device Recall Infinity Direct Nasal Mask
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Manufacturer
Fisher & Paykel Healthcare Inc
Manufacturer Address
Fisher & Paykel Healthcare Inc, 15365 Barranca Parkway, Irvine CA 92618
Source
USFDA
Language
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