Aomori Olympus Co., Ltd. recalls K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage
Recalled Product
K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
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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