RadiaLux Lighted Retractor recall: Contamination
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Why was RadiaLux Lighted Retractor recalled?
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F
- Product
- RadiaLux Lighted Retractor (Pink), REF: 50-101-1
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 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.
- Recall date
- January 18, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)