Product Wiki · Recalls · U.S. FDA — Device Enforcement

NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract. — recall Z-1069-2021

U.S. FDA — Device Enforcement · Japan · 2021-01-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1069-2021
Date of alert
2021-01-04
Country / jurisdiction
Japan
Risk level
Class II
Risk type
recall
Brand
Aomori Olympus Co., Ltd.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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