Aomori Olympus Co., Ltd. recalls NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Produc
Recalled Product
NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI 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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