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U.S. Department of Health and Human Services

Class 2 Device Recall RadiaLux Lighted Retractor

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  Class 2 Device Recall RadiaLux Lighted Retractor see related information
Date Initiated by Firm December 08, 2022
Date Posted January 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-0953-2023
Recall Event ID 91328
Product Classification Retractor - Product Code GAD
Product RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Code Information UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact Kyra Nead
303-886-2549
Manufacturer 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.
FDA Determined
Cause 2		 Equipment maintenance
Action On 11/17/22 customers were verbally notified to quarantine affected devices. On 12/08/22, recall notices were sent to customers asking them to take the following action: 1) Discontinue use of affected devices. 2) Return affected devices to the recalling firm. 3) Complete and return the customer confirmation form that can be emailed to neuro.quality@medtronic.com 3) The notice needs to be shared with all who need to be aware within your organization and any organization where the potentially affected devices have been transferred. Customers with questions are encouraged to call/email: Medtronic Technical Services at 1-888-826-5603/rs.navtechsupport@medtronic.com
Quantity in Commerce 2317
Distribution US Nationwide distribution including in the states of OH, CA, FL, NJ, NY, MN, IN, VA, WA, MS, SC, MO, GA, PA, KS, TN, LA, TX, ME, MA, AL, NC, MD, NH, IL, AZ, MI, NV, MT, OK, SD, RI, CO, CT, NM, NE, DE, WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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