Device product
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.
Z-1483-2022
Product summary
- Firm
- Medtronic Inc
- Event
- Event 90552
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 84 units
- Official record key
device-enforcement:Z-1483-2022
Official wording
Reason: Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
Code information: GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.