Aomori Olympus Co., Ltd. recalls B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A
Recalled Product
B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
Hazard / Issue
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.
Issued by
FDA
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