Devices

Device Recall Portex First Breath Adult Face Tent (Nonlatex)

Model / Serial
Lot Numbers: 10-11
Product Classification
Anesthesiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Armenia, Brazil, Canada, France, Hungary, Italy, Jordan, Japan, Libya, Poland, Russian Federation, and Saudi Arabia.
Product Description
First Breath ¿ Adult Face Tent (Non-latex) 50/CA || Reorder Number: 001490 || Face Tent Is a special type of aerosol mask used when the delivery of oxygen is not the primary objective. Normally this type of mask is used to deliver an aerosol mist to cool and moisturize the nasal passages or sinuses after surgery
Manufacturer
Smiths Medical
1 Event
- Recall of Device Recall Portex First Breath Adult Face Tent (Nonlatex)

Manufacturer

Smiths Medical

Manufacturer Address
Smiths Medical, Hythe, Hythe, Kent United Kingdom
Manufacturer Parent Company (2017)
Smiths Group Plc
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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