Z-1483-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 10, 2022
- Initiation Date
- June 24, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84 units
Product 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.
Reason for Recall
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023