Medtronic Navigation, Inc.: RadiaLux Lighted Retractor (Pink), REF: 50-101-1

Hazard

Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.

Details from the source

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. Quantity: 2317 Lot/code info: UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F

UPC codes

00763000432805

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.