Z-0953-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2023
- Initiation Date
- December 8, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2317
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.
Distribution Pattern
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