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The Food and Drug Administration (FDA) warns all healthcare professionals and establishments on the voluntary recall of affected lots of Covidien DAR Airway Products manufactured by Covidien-USA, imported and distributed by Medtronic Philippines, Inc.:

 

Item Code Description Affected Lot Numbers
352/5877 HYGROBAC S ELECST FHME 18K1188FAX 18L0219FAX
19B0551FAX 19C1353FAX
20F0524FAX 20G0358FAX
18K1189FAX 19B0524FAX
19E1303FAX 19E1304FAX
18L0558FAX 19D0943FAX
20G0357FAX  
350/5879 BARRIERBAC S ELECST FILTER 18L0217FAX 18L0218FAX
18L1034FAX 18L1035FAX
18L1265FAX 19E0227FAX
19E0357FAX 19L0873FAX
20D0772FAX 20D0771FAX
20F0456FAX  

Medtronic International, Ltd. initiated the voluntary recall of the above-mentioned specific lots/batches of Covidien DAR Airway Products. Medtronic has concluded its investigation of potential deviations in the ethylene oxide sterilization processes performed by Steril Milano, the former supplier of their sterilization services for the DAR™ Airway Products. Medtronic analyzed the available sterilization data and conducted validation tests on production lots where data was available. The conclusion of their investigation, testing and analysis has resulted in the need to recall certain lots of the DAR™ Airway Products which are currently under quarantine.

The action is being taken because, for certain production lots where no sterilization process data was available, the manufacturer were unable to validate the sterility of these products and are therefore issuing a recall of only these products.

All products subject to this recall are available in two version, either as clean/non-sterile or sterile, except for DAR™ Ty-Care™ closed suction system devices which are available as sterile devices only. Use of DAR™ TyCare™ closed suction system devices where the sterility cannot be assured may be associated with an extremely unlikely risk of infection, particularly given the clinical application of suction devices and when used in accordance with the Instructions for Use.                 

In light of the foregoing, all concerned healthcare professional, establishments, and the general public are warned to discontinue further use, sale, and distribution of the said affected lots/batches of DAR™ Airway Products.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that product is not sold or made available in the market or areas of jurisdiction.

Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.

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.

Dissemination of this advisory to all concerned is hereby requested.

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