FDA-Device2021-02-17Class II
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.
Aomori Olympus Co., Ltd.
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
7,400,000 (global); 260,395 (US)
Manufactured in
2 Chome 248-1, Okkonoki, Kuroishi, N/A, Japan
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0962-2021Don't want to check this manually?
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