Reported Mar 8, 2017 · Terminated
Check-Flo Performer Introducer Set, 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 Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.
- Lot codes and dates
- Catalog Identifier
RCF-4.0(5.06.07.08.0)- / -BV Codes consist of Lot #RPN #
- Manufacture Date and Expiration Date4860671 RCF-4.0-35-J-BV 2014/03 3/1/2017; 5018663 RCF-4.0-35-J-BV 6/1/2014 6/1/2017; 5152571 RCF-4.0-35-J-BV 8/5/2014 8/5/2017; 5219529 RCF-4.0-35-J-BV 9/4/2014 9/4/2017; 5475523 RCF-4.0-35-J-BV 12/9/2014 12/9/2017; 6125807 RCF-4.0-35-J-BV 9/8/2015 9/8/2018; NS5210596 RCF-4.0-35-J-BV 8/27/2014 8/27/2017; 4790887 RCF-5.0-35-J-BV 2014/02 2/1/2017; 4879368 RCF-5.0-35-J-BV 2014/04 4/1/2017; 4995370 RCF-5.0-35-J-BV 5/1/2014 5/1/2017; 5018661 RCF-5.0-35-J-BV 6/1/2014 6/1/2017; 5105572 RCF-5.0-35-J-BV 7/31/2014 7/31/2017; 5191953 RCF-5.0-35-J-BV 8/14/2014 8/14/2017; 5230090 RCF-5.0-35-J-BV 9/4/2014 9/4/2017; 5335405 RCF-5.0-35-J-BV 10/22/2014 10/22/2017; 5391106 RCF-5.0-35-J-BV 11/18/2014 11/18/2017; 5550365 RCF-5.0-35-J-BV 2/3/2015 2/3/2018; 5632266 RCF-5.0-35-J-BV 3/3/2015 3/3/2018; 5825763 RCF-5.0-35-J-BV 5/8/2015 5/8/2018; NS6041240 RCF-5.0-35-J-BV 8/6/2015 8/6/2018; 4800069 RCF-6.0-35-J-BV 2014/02 2/1/2017; 4938694 RCF-6.0-35-J-BV 2014/05 5/1/2017; 4995361 RCF-6.0-35-J-BV 6/1/2014 6/1/2017; 5026341 RCF-6.0-35-J-BV 6/1/2014 6/1/2017; 5105539 RCF-6.0-35-J-BV 7/18/2014 7/18/2017; 5115956 RCF-6.0-35-J-BV 7/23/2014 7/23/2017; 5191946 RCF-6.0-35-J-BV 8/15/2014 8/15/2017; 5204970 RCF-6.0-35-J-BV 8/28/2014 8/28/2017; 5237288 RCF-6.0-35-J-BV 9/12/2014 9/12/2017; 5306462 RCF-6.0-35-J-BV 10/3/2014 10/3/2017; 5335304 RCF-6.0-35-J-BV 10/20/2014 10/20/2017; 5589594 RCF-6.0-35-J-BV 2/23/2015 2/23/2018; 5621222 RCF-6.0-35-J-BV 2/24/2015 2/24/2018; 5781933 RCF-6.0-35-J-BV 4/30/2015 4/30/2018; 5839252 RCF-6.0-35-J-BV 5/11/2015 5/11/2018; 5933749 RCF-6.0-35-J-BV 7/10/2015 7/10/2018; 5998390 RCF-6.0-35-J-BV 7/28/2015 7/28/2018; 6145159 RCF-6.0-35-J-BV 9/11/2015 9/11/2018; NS6043629 RCF-6.0-35-J-BV 8/9/2015 8/9/2018; NS6332956 RCF-6.0-35-J-BV 11/17/2015 11/17/2018; 4790871 RCF-7.0-35-J-BV 2014/03 3/1/2017; 5018638 RCF-7.0-35-J-BV 6/1/2014 6/1/2017; 5459181 RCF-7.0-35-J-BV 12/11/2014 12/11/2017; 5600122 RCF-7.0-35-J-BV 2/6/2015 2/6/2018; 5765286 RCF-7.0-35-J-BV 4/20/2015 4/20/2018; 5905965 RCF-7.0-35-J-BV 6/15/2015 6/15/2018; 4729143 RCF-8.0-38-J-BV 2014/01 1/1/2017; 4893493 RCF-8.0-38-J-BV 2014/04 4/1/2017; 5018702 RCF-8.0-38-J-BV 6/1/2014 6/1/2017; 5214240 RCF-8.0-38-J-BV 8/26/2014 8/26/2017; 5429421 RCF-8.0-38-J-BV 11/18/2014 11/18/2017; 5486519 RCF-8.0-38-J-BV 1/6/2015 1/6/2018; 5637340 RCF-8.0-38-J-BV 3/2/2015 3/2/2018; 6073269 RCF-8.0-38-J-BV 8/13/2015 8/13/2018
- Catalog Identifier
- Amount recalled
- 854
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.
Free recall alerts
Get alerted about new Cook Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.