The manufacturer of the NIV angled mouthpiece with Notch 22F/15F, advised that devices in lots 32304444, 32305269 and 32306017 were produced with unintended open slits on the side of the mouthpiece body. This allows some of the respiratory gas to escape and thus reduces effectiveness of the related Vivo 45 LS US device. Breas Medical traced these lots and determined that shipments from April 4th, 2023 until July 31st, 2023 could be affected by the issue. Recall Start Date: October 13, 2023
RecallTracker