Devices

Device Recall Flexi Fit Full Face Mask

Model / Serial
Lot numbers for Part Numbers 431A (lot #s: 031120 to 051121), HC431SLL (lot #s: 050607 to 051028), HC431SLM (lot #s: 050609 to 051107) & HC431SLS (lot #s: 050609 to 051107)
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A, HC431SLL, HC431SLM & HC431SLS. CPAP masks.
Manufacturer
Fisher & Paykel Healthcare Inc
1 Event
- Recall of Device Recall Flexi Fit Full Face 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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