Class I recall

2 articles
BenzingaBenzinga··Vandana Singh

FDA Issues Class I Recall for Tandem Diabetes Mobi Pumps Over Insulin Delivery Risk

FDA classifies Class I recall for Tandem Diabetes' Mobi insulin pumps due to false motor failure detection risking insulin delivery interruption.
TNDMFDA recallmedical device
BenzingaBenzinga··Vandana Singh

FDA Issues Class I Recall for Medline Homecare Beds Over Fire and Shock Hazards

FDA issues Class I recall for Medline homecare beds due to fire and electrical shock hazards. One death linked to overheating cords; company distributing revised instructions instead of removal.
MDLNFDA recallfire hazard