Z-1483-2022 Class II Ongoing
FDA device recall Z-1483-2022 was initiated by Medtronic Inc on Jun 24, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 84 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 10, 2022
- Initiation Date
- Jun 24, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1483-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026