B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
US Nationwide distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0962-2021