RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Recall
- Recall Number
- Z-0953-2023
- Event Number
- 91328
- Firm
- Medtronic Navigation, Inc.
- FEI Number
- 1000517638
- Product Code
- GAD
- Status
- Open, Classified
- Root Cause
- Equipment maintenance
- Initiated
- December 8, 2022
- Posted
- January 12, 2023
- Address
- 826 Coal Creek Cir, Louisville, CO, 80027-9710
Description
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
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 [email protected] 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/[email protected]
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.
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