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

FDA device recall Z-0953-2023 · posted 2023-01-12 · Open, Classified

Recall details

Recalling firm

Medtronic Navigation, Inc.

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.

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

Root cause

Equipment maintenance

Status

Open, Classified

Product code

GAD

Quantity affected

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

Date initiated

2022-12-08

Date posted

2023-01-12

Location

Louisville, CO