Summary
The FDA issued a Class II for Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 by Cook Incorporated. Reason: Devices from the affected device lots have labels that state the incorrect expiration dates..
Details
Source
Device Recall
External ID
Z-0499-2025
Action Date
2024-11-27
Status
Ongoing
Category
device
Product Description
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Lot/Code Info: UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020
Quantity Affected: 10 units
Reason for Recall
Devices from the affected device lots have labels that state the incorrect expiration dates.
Distribution
International Distribution to: Korea only
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-14
Company
Bloomington, IN
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 280 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 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 (Cook Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cook Incorporated have FDA actions?
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0499-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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