Recall Z-0151-2020— Xodus Medical Inc

Name: FDA recall Z-0151-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-19

Class II · Terminated

Class II FDA medical device recall by Xodus Medical Inc, initiated 2019-09-19, terminated 2024-03-04. It names one FDA 510(k) clearance: K053433. Product: Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory. Reason: The sterile barrier of some devices may have been affected.

Recalling firm: Xodus Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2019-09-19
Terminated: 2024-03-04
Firm location: New Kensington, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K053433 — CAUTERY TIP CLEANER, MODEL 30500Xodus Medical, Inc.·cleared 2006-01-19

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

Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory

Reason for recall

The sterile barrier of some devices may have been affected

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