FDA Recall
Open, Classified
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
Recall: Z-0346-2025
·
Initiated October 8, 2024
Recall
- Recall Number
- Z-0346-2025
- Event Number
- 95528
- Firm
- Cook Incorporated
- FEI Number
- 1820334
- Product Code
- DQX
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- October 8, 2024
- Posted
- November 8, 2024
- Address
- 750 N Daniels Way, Bloomington, IN, 47404-9120
Description
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
Reason
Affected device lots have labels that state the incorrect expiration dates.
Action
On October 8, 2024, the firm notified affected consignees through Urgent Medical Device Recall letters. Customers were informed of the product issue and instructed to quarantine any affected product that remains unused. Product should be returned to Cook Medical. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235
Distribution
Worldwide - US Nationwide distribution.
Quantity
2,005 US; 1,145 OUS