Devices

Device Recall Ambu AuraGain Single Use Laryngeal Mask Sterile

Model / Serial
Catalog Number:408300000 Size #3:All lots from 1632796 through lot number 1808911except lot number 1779966,1782239, 1795914 Catalog Number: 408400000 Size #4 All lots from 1632799 through lot number 1790075. Catalog Number:408500000 Size #5 All lots from 1632802 through lot number 1810863.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Please see attached consignee list
Product Description
Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile || for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
Manufacturer
Ambu Inc.
1 Event
- Recall of Device Recall Ambu AuraGain Single Use Laryngeal Mask Sterile

Manufacturer

Ambu Inc.

Manufacturer Address
Ambu Inc., 6230 Old Dobbin Ln Ste 250, Columbia MD 21045-5955
Manufacturer Parent Company (2017)
Vsri Holding Ii Aps
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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