Aomori Olympus Co., Ltd. recalls SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Pro
Recalled Product
SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive 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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