The Food and Drug Administration (FDA) informs the public that the medical device product Air Life Gauze Bandage 4″ x 10 yds, 40’s/40’s 19 x 10 mesh with CPR No. MDR-08861, has been registered by the Market Authorization Holder (MAH), Airlife International Trading Corporation, in accordance to existing FDA rules and regulations.
Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2018-309 is hereby lifted.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.
To report any sale or distribution of unregistered medical device products, email us at [email protected].
The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.
Dissemination of this advisory to all concerned is hereby requested.
Attachment:->FDA Advisory No.2018-309-A