FDA Recall
Open, Classified
Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Recall: Z-0347-2025
·
Initiated October 8, 2024
Recall
- Recall Number
- Z-0347-2025
- 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 Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
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
5,953 US; 2,528 OUS