EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880

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: 00821925033160 Lot Number: 380777

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