FDA Advisory No. 2020-158 || Public Health Warning Against the Purchase and Use of Counterfeit Medical Device “Cos-Med Volumetric Solution Infusion Set”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the counterfeit Cos-Med Volumetric Solution Infusion Set. Please see particulars/details of the original vs. the counterfeit product  on the attachment below…

The Market Authorization Holder (MAH), Cosmo Medical, Inc., reported to the FDA that the aforementioned medical device is counterfeit.

Counterfeit product has not go through the required safety assessment and the FDA verification process. This product pose potential health hazards to the consuming public since its safety and purity cannot be guaranteed.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product.

All concerned establishments are warned not to distribute, the said counterfeit medical device.

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

The Bureau of Customs is urged to restrain the entry of this counterfeit product.

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, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-158

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