The Food and Drug Administration (FDA) warns all healthcare professionals and establishments on the voluntary recall of affected lots of BD Venflon™ Pro Safety Needle Protected I.V. Cannula with FDA registration number MDR-09771 manufactured by Becton Dickinson Holdings Pte. Ltd., imported and distributed by KSM Healthcare, Inc.
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BD Venflon™ Pro Safety Needle Protected I.V. Cannula
Based on the medical device recall notification of KSM Healthcare Inc. BD issued a Field Safety Notice (FSN) to advise users of the above-mentioned medical device that the device may exhibit leakage from the injection port. BD’s ongoing post market surveillance process and after a review and further discussions with EU Regulators, BD has decided, that this FSN escalated to be a product recall of all remaining inventory of the afore stated medical device. BD is recalling all affected BD Venflon™ Pro Safety Needle Protected I.V. Cannula that has been sterilized by ethylene oxide (EtO).
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 BD Venflon™ Pro Safety Needle Protected I.V. Cannula
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.