Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxia
Summary
The FDA issued a Class II for Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire by Medtronic Inc. Reason: Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging..
Details
Source
Device Recall
External ID
Z-1483-2022
Action Date
2022-08-10
Status
Ongoing
Category
device
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.
Lot/Code Info: GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023
Quantity Affected: 84 units
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
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-24
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 97 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Inc has 83 FDA actions in our database, including 46 recalls and 37 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Inc have FDA actions?
Medtronic Inc has 83 FDA actions in our database, including 46 recalls and 37 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1483-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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