Summary
The FDA issued a Class II for RadiaLux Lighted Retractor (Pink), REF: 50-101-1 by Medtronic Navigation, Inc.. Reason: Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection..
Details
Source
Device Recall
External ID
Z-0953-2023
Action Date
2023-01-18
Status
Ongoing
Category
device
Product Description
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Lot/Code Info: UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F
Quantity Affected: 2317
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-08
Company
Louisville, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Navigation, Inc. has 23 FDA actions in our database, including 13 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Navigation, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Navigation, Inc. have FDA actions?
Medtronic Navigation, Inc. has 23 FDA actions in our database, including 13 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0953-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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