Reported Mar 8, 2017 · Terminated
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Cook Inc.
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 Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
- Lot codes and dates
- Catalog IdentifierCFM-200 Codes consist of Lot #, RPN #
- Manufacture Date and Expiration Date
5383334 CFM-200 10/22/2014 10/22/20175413859 CFM-200 11/3/2014 11/3/20175534624 CFM-200 12/22/2014 12/22/20175596858 CFM-200 1/21/2015 1/21/20185596860 CFM-200 1/21/2015 1/21/20185658131 CFM-200 2/16/2015 2/16/20185683532 CFM-200 2/27/2015 2/27/20185683534 CFM-200 2/27/2015 2/27/20185687431 CFM-200 3/2/2015 3/2/20185741270 CFM-200 3/23/2015 3/23/20185781086 CFM-200 4/6/2015 4/6/20185831551 CFM-200 4/23/2015 4/23/20185836503 CFM-200 4/27/2015 4/27/20185864629 CFM-200 5/6/2015 5/6/20185918539 CFM-200 5/29/2015 5/29/20185952200 CFM-200 6/11/2015 6/11/20185971838 CFM-200 6/19/2015 6/19/20186072470 CFM-200 7/28/2015 7/28/20186072479 CFM-200 7/28/2015 7/28/20186165074 CFM-200 8/29/2015 8/29/20186223829 CFM-200 9/22/2015 9/22/20186255406 CFM-200 10/2/2015 10/2/20186255407 CFM-200 10/2/2015 10/2/20186255408 CFM-200 10/2/2015 10/2/20186276169 CFM-200 10/12/2015 10/12/20186278920 CFM-200 10/12/2015 10/12/20186311713 CFM-200 10/23/2015 10/23/20186332089 CFM-200 10/29/2015 10/29/20186360092 CFM-200 11/6/2015 11/6/2018NS5226487 CFM-200 8/20/2014 8/20/2017NS5514147 CFM-200 12/12/2014 12/12/2017NS5658130 CFM-200 2/16/2015 2/16/2018NS5712801 CFM-200 3/11/2015 3/11/2018NS5759898 CFM-200 3/30/2015 3/30/2018NS5864632 CFM-200 5/6/2015 5/6/2018NS5871863 CFM-200 5/11/2015 5/11/2018NS5945483 CFM-200 6/9/2015 6/9/2018NS6091885 CFM-200 8/4/2015 8/4/2018NS6126832 CFM-200 8/17/2015 8/17/2018NS6147094 CFM-200 8/24/2015 8/24/2018NS6360093 CFM-200 11/6/2015 11/6/2018
- Amount recalled
- 1,589
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
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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