Reported Nov 20, 2024 · Ongoing

Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G…

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 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
Lot codes and dates
  • RPN /UDI-DI/ Lots

    127 of 127 codes

    • CMW-14-190-12G/
    • 00827002507876/
    • 15763571
    • 15773059
    • 15783003
    • 15885574
    • NS15821244
    • NS15849650
    • CMW-14-190-18G/
    • 00827002507883/
    • 15763579
    • 15769462
    • 15802931
    • 15811662
    • 15898546
    • 15925115
    • 15943888
    • 15974443
    • 15802931X
    • NS15849651
    • CMW-14-190-25G/
    • 00827002507890/
    • 15778254
    • 15791923
    • 15802932
    • 15849652
    • 15891914
    • 15891915
    • 15995205
    • CMW-14-190-6G/
    • 00827002507869/
    • 15800162
    • 15907477
    • 16018911
    • CMW-14-300-12G/
    • 00827002507913/
    • 15718982
    • 15763552
    • 15763561
    • 15763577
    • 15763604
    • 15763605
    • 15794897
    • 15802924
    • 15858395
    • 15858399
    • 15885578
    • 15891916
    • 15898543
    • 15915909
    • 15943896
    • 15945778
    • 15952518
    • 15956556
    • 15958706
    • NS15843567
    • NS15892396
    • CMW-14-300-18G/
    • 00827002507920/
    • 15718980
Amount recalled
2,005 US; 1,145 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.

Free recall alerts

Get alerted about new Cook Incorporated recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:56 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.