Aomori Olympus Co., Ltd. recalls PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage
Recalled Product
PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.
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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