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The Food and Drug Administration (FDA) informs the public that Fresenius Medical Care Philippines, Inc., Marketing Authorization Holder (MAH), has reported that it has completed the recall and removal of AV-Set B DT INF-E Blood Tubing System (see Figures 1 and 2) with DVR No. 8574 (Article No. AP16641) from the Philippine market.

Dissemination of the information to all concerned is requested.

FDA Advisory No. 2018-240