International Medical Devices Database

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

6 devices in the database

Device Recall Fisher & Paykel CPAP Mask

Model / Serial
Lot Numbers for Part Numbers: 400HC202 (lot #s: 040802 to 051222),400HC203 (lot #s: 040719 to 051103), 400HC209 (lot #s: 041108 to 050920), 400HC502 (lot #s: 040825 to 060201), 400HC503 (lot #s:040830 to 051028), 400HC505 (lot #s: 050223 to 050726), 400HCHC510 (lot #s: 051007 to 051028) , 900HC402 (lot #s: 010918 to 060203), 900HC405 (lot#s: 030924 to 030925), 900HC406 (lot #s: 031110 to 060403), 900HC412 (lot #s: 020108 to 060203), 900HC441 (lot #s: 031110 to 060424) & 900HC463 (lot #s: 020108 to 040604)
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuser holes),400HC203 (Elbow + vent NR valve), 400HC209 (Oracle 452 flexitube kit vent NR), 400HC502 (HC407 mask no headgear), 400HC503 (HC431 mask no headgear), 400HC505 (Infinity HC481 mask base), 400HCHC510 (HC406 mask no headgear) , 900HC402 (Aclaim mask no headgear), 900HC405 (HC405 sleep lab mask kit), 900HC406 (HC405 mask no headgear), 900HC412 (Aclaim flexitube kit), 900HC441 (Elbow diffuser and swivel) & 900HC463 (HC451 flexitube kit). CPAP masks.

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.

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.

Device Recall FlexiFix Nasal Mask

Model / Serial
Lot numbers for Part Numbers: HC405A (lot #s: 020930 to 060410) , HC405SL (lot #s: 040225 to 040325), HC405U (lot #s: 030922 to 060217), HCHC406A (lot #s: 050830 to 060123), HC406SL (lot #s: 051021 to 051220), HC407A (lot #s: 031124 to 060207), HC407SL (lot #s: 040921 to 060202) & HC407U (lot #s: 040407 to 060113)
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL & HC407U. CPAP masks.

Device Recall Aclaim Nasal Mask

Model / Serial
Lot numbers for Part Numbers: HC401A (lot #s: 020521 to 060217) & 900HC401 (lot #s: 010829 to 020517)
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A & 900HC401. CPAP masks.

One more

3 manufacturers with a similar name

Learn more about the data here

Fisher & Paykel Healthcare Inc

Manufacturer Address
Fisher & Paykel Healthcare Inc, 22982 Alcalde Drive 101, Laguna Hills CA 92653
Source
USFDA

Fisher & Paykel Healthcare Inc

Manufacturer Parent Company (2017)
Fisher & Paykel Healthcare Corporation Limited
Manufacturers representative
Saudi Health Services Co. Ltd.
Source
SFDA

Fisher & Paykel Healthcare Inc

Manufacturer Address
Fisher & Paykel Healthcare Inc, 5900 Skylab Rd, Huntington Beach CA 92647-2061
Manufacturer Parent Company (2017)
Fisher & Paykel Healthcare Corporation Limited
Source
USFDA

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Disclaimer

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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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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