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Aomori Olympus Co., Ltd. recalls B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical
Recalled February 17, 2021 · FDA recall Z-0961-2021 · Aomori Olympus
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. · FDA Class II
Units
7,400,000 (global); 260,395 (US)
Sold at
US Nationwide distribution.
Description
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.
Product
B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Manufacturer(s)
Aomori Olympus Co., Ltd.
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →