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Crédits
Devices
INSPIRA AIR BALLOON DILATION SYSTEM
Modèle / numéro de série
Model Catalog: BC8524A (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BC0524A (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BC0524AZ (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BC0724A (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BC0724AZ (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BC1040A (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BC1440AZ (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BC1440A (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BC1040AZ (Lot serial: >10 NUMBERS CONTACT MFR)
Description du dispositif
INSPIRA AIR BALLOON DILATION SYSTEM
Manufacturer
JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.
1 Event
Rappel de INSPIRA AIR BALLOON DILATION SYSTEM
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Fabricant
JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.
Adresse du fabricant
MARKHAM
Société-mère du fabricant (2017)
Johnson & Johnson
Source
HC
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Acclarent Inspira Air Balloon Dilation System
Modèle / numéro de série
Model: Product Codes: BC0524A, BC0524AZ, BC0724A, BC0724AZ, BC1040A, BC1040AZ, BC1440A, BC1440AZ, Affected: All lots
Manufacturer
Acclarent Inc
Inspira AIR Balloon Dilation System, size 18X40mm
Modèle / numéro de série
Description du dispositif
Medical Device Safety Alert: Acclarent Inspira AIR Balloon Dilation System, size 18X40mm
Manufacturer
Acclarent
Device Recall Inspira AIR Balloon Dilation system
Modèle / numéro de série
Product code: BC1040A; All lots manufactured after March 1, 2011
Classification du dispositif
Ear, Nose, and Throat Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Description du dispositif
Inspira AIR Balloon Dilation system. || Size 10 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.
Manufacturer
Acclarent, Inc.
Device Recall Inspira AIR Balloon Dilation system
Modèle / numéro de série
Product code: BC1240A; All lots manufactured after March 1, 2011
Classification du dispositif
Ear, Nose, and Throat Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Description du dispositif
Inspira AIR Balloon Dilation system. || Size 12 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.
Manufacturer
Acclarent, Inc.
Device Recall Inspira AIR Balloon Dilation system
Modèle / numéro de série
Product code: BC1440A; All lots manufactured after March 1, 2011
Classification du dispositif
Ear, Nose, and Throat Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Description du dispositif
Inspira AIR Balloon Dilation system. || Size 14 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.
Manufacturer
Acclarent, Inc.
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