Class 2 Device Recall Approach Hydro ST Micro Wire Guide

• Date Initiated by Firm: October 08, 2024
• Date Posted: November 08, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0347-2025
• Recall Event ID: 95528
• 510(K)Number: K091385
• Product Classification: Wire, guide, catheter - Product Code DQX
• Product: Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
• Code Information: RPN /UDI-DI/ Lots: HMW-14-135-ST/ 00827002529373/ 15735501 15765954 15863269 15874634 15907468 15943872 15943886 15971771 15974437 16012937 15971771X 16012937X HMW-14-190-ST/ 00827002529380/ 15726043 15726044 15765947 15765955 15778260 15800165 15800166 15811656 15811657 15821245 15829376 15831156 15835857 15849644 15858389 15874633 15885580 15891903 15894221 15894222 15907469 15908739 15943873 15943874 15943881 15943882 15945799 15945801 15952502 15971778 15971779 15979320 15988603 15999088 15999089 16018914 16018917 16018919 15874633X 16018919X NS15765956 NS15769470 NS15783001 NS15794893 NS15802918 NS15821246 NS15835858 NS15849643 NS15915900 NS16029493 HMW-14-300-ST/ 00827002529397/ 15718978 15718979 15720963 15726042 15726045 15731209 15731210 15735502 15765946 15765948 15765949 15765950 15765951 15765952 15765953 15769463 15769464 15769465 15769466 15769467 15769469 15778257 15778258 15778259 15794890 15794891 15800167 15802919 15802920 15802921 15811658 15816909 15816910 15821248 15821250 15829375 15829377 15831157 15831159 15843561 15845744 15845745 15845746 15858390 15858391 15858392 15863266 15863267 15863268 15879455 15885581 15885582 15885583 15885584 15891901 15891902 15892394 15894223 15894224 15894225 15894226 15894227 15898542 15902068 15902069 15902070 15925109 15925110 15925111 15925113 15925114 15943875 15943876 15943877 15943878 15943879 15943880 15943883 15943884 15943885 15945800 15952500 15952501 15958703 15971772 15971773 15971774 15971775 15971776 15971777 15971780 15979321 15988604 15995198 15995199 15995200 16004716 16004717 16004718 16004719 16004720 16004721 16010288 16010289 16018915 16018918 16025193 16029492 16042142 16042143 16042144 16042145 15726042X 15843560X 15902070X 15943885X NS15720964 NS15766147 NS15769468 NS15794892 NS15800168 NS15802922 NS15821247 NS15821249 NS15845747 NS15856480 NS15858393 NS15892395 NS16018395
• FEI Number: 1820334
• Recalling Firm/ Manufacturer: Cook Incorporated; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Department; 812-339-2235
• Manufacturer Reason for Recall: Affected device lots have labels that state the incorrect expiration dates.
• FDA Determined Cause: Labeling Change Control
• 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
• Quantity in Commerce: 5,953 US; 2,528 OUS
• Distribution: Worldwide - US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DQX