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Aomori Olympus Co., Ltd. recalls INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: Used with endoscopes to perform endoscopic
Recalled February 17, 2021 · FDA recall Z-1025-2021 · Aomori Olympus
Hazard
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. · FDA Class II
Units
7,400,000 (globally); 260,395 (US)
Sold at
US Nationwide distribution.
Description
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.
Product
INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Manufacturer(s)
Aomori Olympus Co., Ltd.
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →