The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Reason for recall: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Distribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Hon Quantity: 84,570 units (4489 US, 80081 OUS) Lot/code info: Model: TB-0520FCS; Catalog Number/Product Code: N5423930; UDI: 04953170383571, 04953170383578; Lots: All
04953170383571, 04953170383578
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.