RadiaLux Lighted Retractor (Pink), REF: 50-101-1
- Company
- Medtronic Navigation, Inc.
- Recall Initiated
- December 8, 2022
- Posted
- January 12, 2023
- Recall Number
- Z-0953-2023
- Quantity
- 2317
- Firm Location
- Louisville, CO
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.
Lot / Code Info
UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F
Root Cause
Equipment maintenance
Action Taken
On 11/17/22 customers were verbally notified to quarantine affected devices. On 12/08/22, recall notices were sent to customers asking them to take the following action: 1) Discontinue use of affected devices. 2) Return affected devices to the recalling firm. 3) Complete and return the customer confirmation form that can be emailed to neuro.quality@medtronic.com 3) The notice needs to be shared with all who need to be aware within your organization and any organization where the potentially affected devices have been transferred. Customers with questions are encouraged to call/email: Medtronic Technical Services at 1-888-826-5603/rs.navtechsupport@medtronic.com