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-14-190-12GCMW-14-190-18GCMW-14-190-25GCMW-14-190-6GCMW-14-300-12GCMW-14-300-18GCMW-14-300-25GCMW-14-300-6G
- Lot codes and dates
- RPN /UDI-DI/ Lots
127 of 127 codes
CMW-14-190-12G/00827002507876/15763571157730591578300315885574NS15821244NS15849650CMW-14-190-18G/00827002507883/157635791576946215802931158116621589854615925115159438881597444315802931XNS15849651CMW-14-190-25G/00827002507890/15778254157919231580293215849652158919141589191515995205CMW-14-190-6G/00827002507869/158001621590747716018911CMW-14-300-12G/00827002507913/15718982157635521576356115763577157636041576360515794897158029241585839515858399158855781589191615898543159159091594389615945778159525181595655615958706NS15843567NS15892396CMW-14-300-18G/00827002507920/15718980
- RPN /UDI-DI/ Lots
- 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.
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