Devices

Device Recall Oracle Oral Mask

Model / Serial
Lot numbers for Part Numbers: 900HC451 (lot #s: 011001 to 011016), 900HC451T (lot #s: 011024 to 020517), HC451A (lot #s: 020523 to 040907), HC452A (lot #s: 031215 to 060503) & HC452F (lot #s: 040719 to 041102)
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A & HC452F. CPAP masks.
Manufacturer
Fisher & Paykel Healthcare Inc
1 Event
- Recall of Device Recall Oracle Oral Mask

Manufacturer

Fisher & Paykel Healthcare Inc

Manufacturer Address
Fisher & Paykel Healthcare Inc, 15365 Barranca Parkway, Irvine CA 92618
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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