Aomori Olympus Co., Ltd. recalls B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Pro
Recalled Product
B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
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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