Medline Cardiac Catheterization Kits Recalled for Rescinded FDA Clearance
Medline Industries is recalling 19,189 cardiac catheterization kits nationwide because certain syringe, guidewire, and tubing components had their FDA premarket notification (510(k)) clearances rescinded, meaning they were distributed without valid regulatory authorization.
- Product
- Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART
- Category
- Medical Device
- Distribution
- Distributed nationwide