Reported Mar 8, 2017 · Terminated
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial…
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?
- Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
- Lot codes and dates
- Catalog Identifier
KCFN-4.0(5.06.07.0)- / -RA-(S)-HC Codes consist of Lot #RPN #
- Manufacture Date and Expiration Date
2,630 of 2,630 codes
4427564XKCFN-4.0-18-13-RA-HC8/21/20148/21/20174427564XXKCFN-4.0-18-13-RA-HC8/21/20148/21/20174427564XXXKCFN-4.0-18-13-RA-HC8/21/20148/21/20174427566XKCFN-4.0-18-13-RA-HC2014/033/1/20174427568XKCFN-4.0-18-13-RA-HC2014/033/1/20174610803XKCFN-4.0-18-13-RA-HC2014/033/1/20174954615KCFN-4.0-18-13-RA-HC6/1/20146/1/20175087583KCFN-4.0-18-13-RA-HC8/1/20148/1/20175087583XKCFN-4.0-18-13-RA-HC8/1/20148/1/20175102705KCFN-4.0-18-13-RA-HC8/11/20148/11/20175102705XKCFN-4.0-18-13-RA-HC8/11/20148/11/20175260392KCFN-4.0-18-13-RA-HC10/6/201410/6/20175260392XKCFN-4.0-18-13-RA-HC10/6/201410/6/20174427454XKCFN-4.0-18-23-RA-HC8/21/20148/21/20174427454XXKCFN-4.0-18-23-RA-HC8/21/20148/21/2017
- Catalog Identifier
- Amount recalled
- 41,975
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.
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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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