Recall Z-0347-2025
Cook Incorporated · initiated October 8, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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…
Reason for recall
Affected device lots have labels that state the incorrect expiration dates.
FDA-determined cause: Labeling Change Control
Action taken
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
Details
- Recall number
- Z-0347-2025
- Initiated
- October 8, 2024
- Posted by FDA
- November 8, 2024
- Product code
- DQX – Wire, Guide, Catheter
- Quantity
- 5,953 US; 2,528 OUS
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- Cook Incorporated, Bloomington, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0346-2025 Class II | Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers:…Affected device lots have labels that state the incorrect expiration dates. | 10/08/2024Open, Classified |