Recall Z-0953-2023— Medtronic Navigation, Inc.

Name: FDA recall Z-0953-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-08

Class II · Ongoing

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2022-12-08. FDA's recall record names no specific 510(k) clearance for this event. Product: RadiaLux Lighted Retractor (Pink), REF: 50-101-1. Reason: Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-08
Firm location: Louisville, CO, United States

Product description

RadiaLux Lighted Retractor (Pink), REF: 50-101-1

Reason for recall

Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.

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