FDA Medical devices recall ·
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 recall
- Recall number
- Z-0499-2025
- Date
- (initiated October 14, 2024)
- Company / brand
- Cook Incorporated
750 N Daniels Way, Bloomington, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 10 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Why was it recalled?
Devices from the affected device lots have labels that state the incorrect expiration dates.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020
Distribution
International Distribution to: Korea only
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0499-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.