Cardinal Care Premium Disposable Syringes with Mounted Needle 의 안전성 경고

Safety alert

2018-158

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/505154-fda-advisory-no-2018-158

Fda advisory no. 2018-158 lifting the advisory of cardinal care premium disposable syringes with mounted needle under fda advisory no. 2018-068, subject “public health warning against the purchase and use of the unregistered medical device products” the food and drug administration (fda) informs the public that the advisory on the medical device product “cardinal care premium disposable syringes with mounted needle” under fda advisory no. 2018-068 dated 07 march 2018 is hereby lifted pursuant to the compliance of the market authorization holder to existing and applicable laws, rules, and regulations. fda approved on the stickering of the correct registration no. (dvr-7937) on the blister pouch of the 9,544 pcs. recalled cardinal care premium disposable syringes with mounted needle with lot no. 170725 expiring on 24 july 2022. the provisions of fda advisory no. 2018-068 indicating unregistered medical device products are still in effect.  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 existing laws, rules, and regulations.  for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it. . attachments: fda advisory no. 2018-158.Pdf.