FDA recall Z-1024-2021

Aomori Olympus Co., Ltd. · Class II · device

Product

INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-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.

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2021-01-04
Report date
2021-02-17
Termination date
2024-03-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kuroishi, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1024-2021