All concerned healthcare professionals and establishments are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary product recall of selected lots of Terumo® Needle with MDR No. 00802 (see photos of the affected product above), manufactured by Terumo Philippines Corporation.
Terumo Marketing Philippines Inc. received a customer complaint that the blister seals of the above-mentioned medical device are narrows or misaligned. After the investigation, it was observed that the sealing portion (width) of the blister package was below the manufacturing standard of 1.5mm and a small opening on the package resulting to seal breach was observed.
The reason for recall is the potential loss of packaging integrity that may compromise the sterility of the subject medical device product. There have been no reported patient injuries associated to this issue.
All concerned healthcare professionals and establishments are advised to discontinue further use, sale and distribution of the said affected medical device product.
For more information and inquiries, please email us at [email protected] or call the Product Research and Standards Development Division of the FDA – Center for Device Regulation, Radiation Health and Research at 857-1900 local 8301.
Dissemination of the information to all concerned is requested.