Reported Aug 10, 2022 · Ongoing
Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a…
Medtronic Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc · 710 Medtronic Pkwy Mailstop Ls245 · Minneapolis, MN · 55432-5603
Is this the product you have?
- 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.
- Lot codes and dates
- GTIN/UPN 00643169850491
- Lot Number222066656
- Expiration Date04/13/2023
- Amount recalled
- 84 units
Where it was sold
- Nationwide
Why it was recalled
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
This product could cause temporary or reversible health problems — stop using it.
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