Medline Sprinter OTW recall
Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted…
Why was Medline Sprinter OTW recalled?
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023
- Product
- Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted…
- Recalling firm
- Medtronic Inc
- Quantity
- 84 units
- Distribution
- US Nationwide distribution.
- Recall date
- August 10, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)