Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.
Recall
- Recall Number
- Z-1483-2022
- Event Number
- 90552
- Firm
- Medtronic Inc
- FEI Number
- 3001504994
- Product Code
- LOX
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- June 24, 2022
- Address
- 710 Medtronic Pkwy, Mailstop Ls245, Minneapolis, MN, 55432-5603
Description
Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
The firm issued a recall notice on 06/24/2022 by US Mail. Instruction to Customers: 1. Identify and quarantine all unused affected products. 2. Return all unused affected products in your inventory to Medtronic for replacement product or destroy all unused affected products in your inventory at your location. To initiate a product return contact Medtronic Customer Service at 800-854-3570. You local Medtronic Representative can assist you as necessary in initiating the return of this product. 3. Complete the enclosed Customer Confirmation Form and email it to [email protected]. 4. Consignees are asked to forward the notification to those who need to be aware within the organization and to any location which the devices have been distributed.
US Nationwide distribution.
84 units