Cook Incorporated Recalls Approach CTO Micro Wire Guide for Incorrect Expiration Dates
Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates printed on product labels. Contact the manufacturer for corrected expiration information.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II device has incorrect expiration dates on its label, creating a risk of harm if expired devices are used in clinical procedures. No injuries or hospitalizations have been reported, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' which yields a maximum score of 3 (High).
Plain-English summary
Cook Incorporated is recalling Approach CTO Micro Wire Guide, model RPN CMW-14-190-25G, GPN G50789, because devices from the affected lots have labels that state incorrect expiration dates.
The recall affects 10 units distributed to Korea. The affected lot numbers are NS15635381, NS15618280, NS15466311, NS15212224, and NS14992020 (UDI-DI: 00827002507890).
If you have received this device, contact Cook Incorporated for information regarding the correct expiration date.
The recalled product
- Product
- Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
- Manufacturer
- Cook Incorporated
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00827002507890
- Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020
Distribution
Distribution scope not specified by the agency.
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