Recall Z-0969-2021— Aomori Olympus Co., Ltd.

Name: FDA recall Z-0969-2021
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: K950729. Product: PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.. 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

K950729 — OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)Olympus America, Inc.·cleared 1995-03-17

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

PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.

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.