FDA recall Z-0953-2023

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2022-12-08

Report date

2023-01-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Louisville, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0953-2023