Recall Z-0968-2021— Aomori Olympus Co., Ltd.

Name: FDA recall Z-0968-2021
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: K091495. Product: B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.. 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

K091495 — SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-AOlympus Medical Systems Corporation·cleared 2009-09-03

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

B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.

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.