Reported Nov 20, 2024 · Ongoing

Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST

Cook Incorporated

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120

Is this the product you have?

  • Approach Hydro ST Micro Wire Guide; Catalog
  • prefix HMW Reference Part NumbersHMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Lot codes and dates
  • RPN /UDI-DI/ Lots

    197 of 197 codes

    • 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
Amount recalled
5,953 US; 2,528 OUS

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Affected device lots have labels that state the incorrect expiration dates.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.