EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855

Reason: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

Code information: UDI-DI: 00821925033221 Lot Numbers: 373808, 374005, 379746, 379747, 379835, 379836, 381157

Distribution pattern: Nationwide. Foreign: AU BR BR CA DE HK IN JP SG