Recall Z-0953-2023 ยท GAD Retractor
Medtronic Navigation, Inc.
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
| Date | Jan 12, 2023 (initiated Dec 8, 2022) |
| Status | Open, Classified |
| Reason | Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection. |
| Root cause | Equipment maintenance |
| Action | 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: Medtro |
| Quantity | 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, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.