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.
Reported: March 30, 2016 Initiated: February 10, 2016 #Z-1236-2016
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.
Reason for Recall
Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the problem during final quality control at manufacturing site. Damage to the sterile barrier (the pouch) may compromise a medical device's sterility,leading to contamination of the product and,ultimately,patient complications.
Details
- Recalling Firm
- Ambu Inc.
- Units Affected
- Total Numbers of unit distributed: 45990 pes (USA)
- Distribution
- Please see attached consignee list
- Location
- Columbia, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ambu Inc.. Units affected: Total Numbers of unit distributed: 45990 pes (USA).
Why was this product recalled? ▼
Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the problem during final quality control at manufacturing site. Damage to the sterile barrier (the pouch) may compromise a medical device's sterility,leading to contamination of the product and,ultimately,patient complications.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 30, 2016. Severity: Moderate. Recall number: Z-1236-2016.
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