medical Class II Updated 2021-02-17

Aomori Olympus Co., Ltd. recalls INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423

Recalled Product

INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - 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.

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

Distribution: Nationwide (United States)
Lot/Code Info: 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV
View official government recall

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