Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Recall
- Recall Number
- Z-1247-2021
- Event Number
- 87284
- Firm
- Medtronic Vascular
- FEI Number
- 1220452
- Product Code
- DQY
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 15, 2021
- Terminated
- June 15, 2023
- Address
- 35-37A Cherry Hill Drive, Danvers, MA, 01923-2565
Description
Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Sterility may be compromised due to an unsealed pouch
Medtronic issued 15-Jan-2021 Medical Device Correction letter via UPS 2-day to consignees stating reason for recall, health risk, and action to take: Medtronic records indicate that your facility has received one or more of the affected Launcher Guide Catheters. As a result, Medtronic requests that you immediately take the following actions: "Identify and quarantine all unused affected 6F Launcher Guide Catheters as listed in the table above. "Return/Exchange all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at1-800-716-6700 to initiate a product return/exchange. Your local Medtronic Representative can assist you in thereturn of this product. "Please complete the enclosed Customer Confirmation Form and email to [email protected]. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Questions regarding this communication, please contact your Medtronic Field Representative.
Nationwide
10 Units