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

FDA Recall #Z-0953-2023 — Class II — December 8, 2022

Recall #Z-0953-2023 Date: December 8, 2022 Classification: Class II Status: Ongoing

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.

Recalling Firm

Medtronic Navigation, Inc. — Louisville, CO

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product 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.

Code Information

UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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