medical Class II Updated 2022-08-10

Medtronic Inc recalls Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Spr

Recalled 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.

Hazard / Issue

Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023
View official government recall

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