Recall Z-1047-2021— Aomori Olympus Co., Ltd.

Name: FDA recall Z-1047-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-04

Class II · Terminated

Class II FDA medical device recall by Aomori Olympus Co., Ltd., initiated 2021-01-04, terminated 2024-03-11. It names one FDA 510(k) clearance: K153625. Product: NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.. Reason: 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..

Recalling firm: Aomori Olympus Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2021-01-04
Terminated: 2024-03-11
Firm location: Kuroishi, N/A, Japan

510(k) clearances named in this recall

1 on FDA's record

K153625 — Single Use Injector NM600/610Olympus Medical Systems Corp.·cleared 2016-02-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.