Reported Mar 8, 2017 · Terminated
Check-Flo Introducer Hausdorf-Lock Atrial, 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 Introducer Hausdorf-Lock Atrial, 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 IdentifierRCFW-7.0(8.0)-38-75-RB-HLA-091100-BV Codes consist of Lot #, RPN #
- Manufacture Date and Expiration Date4826254 RCFW-4.0-35-BV 2014/03 3/1/2017; 5040369 RCFW-4.0-35-BV 6/1/2014 6/1/2017; 5364287 RCFW-4.0-35-BV 10/15/2014 10/15/2017; 5379911 RCFW-4.0-35-BV 10/21/2014 10/21/2017; 5400933 RCFW-4.0-35-BV 10/29/2014 10/29/2017; 5435105 RCFW-4.0-35-BV 11/11/2014 11/11/2017; 5462040 RCFW-4.0-35-BV 11/20/2014 11/20/2017; 5474624 RCFW-4.0-35-BV 11/25/2014 11/25/2017; NS5424653 RCFW-4.0-35-BV 11/6/2014 11/6/2017; NS5424654 RCFW-4.0-35-BV 11/6/2014 11/6/2017; 5213872 RCFW-5.0-35-BV 8/14/2014 8/14/2017; 5273219 RCFW-5.0-35-BV 9/10/2014 9/10/2017; 5302128 RCFW-5.0-35-BV 9/23/2014 9/23/2017; 5354215 RCFW-5.0-35-BV 10/10/2014 10/10/2017; 5400931 RCFW-5.0-35-BV 10/29/2014 10/29/2017; 5523548 RCFW-5.0-35-BV 12/17/2014 12/17/2017; 5681717 RCFW-5.0-35-BV 2/26/2015 2/26/2018; 5690760 RCFW-5.0-35-BV 3/3/2015 3/3/2018; 5701193 RCFW-5.0-35-BV 3/6/2015 3/6/2018; 6004897 RCFW-5.0-35-BV 7/2/2015 7/2/2018; 5260343 RCFW-6.0-35-BV 9/4/2014 9/4/2017; 5275648 RCFW-6.0-35-BV 9/11/2014 9/11/2017; 5308224 RCFW-6.0-35-BV 9/24/2014 9/24/2017; 5312947 RCFW-6.0-35-BV 9/25/2014 9/25/2017; 5368247 RCFW-6.0-35-BV 10/16/2014 10/16/2017; 5383333 RCFW-6.0-35-BV 10/22/2014 10/22/2017; 5444866 RCFW-6.0-35-BV 11/13/2014 11/13/2017; 5585193 RCFW-6.0-35-BV 1/16/2015 1/16/2018; 5681719 RCFW-6.0-35-BV 2/26/2015 2/26/2018; 5690162 RCFW-6.0-35-BV 3/3/2015 3/3/2018; 5692849 RCFW-6.0-35-BV 3/4/2015 3/4/2018; 5974636 RCFW-6.0-35-BV 6/20/2015 6/20/2018; 4906939 RCFW-7.0-35-BV 2014/04 4/1/2017; 4987018 RCFW-7.0-35-BV 5/1/2014 5/1/2017; 5228810 RCFW-7.0-35-BV 8/21/2014 8/21/2017; 5275669 RCFW-7.0-35-BV 9/11/2014 9/11/2017; 5301927 RCFW-7.0-35-BV 9/22/2014 9/22/2017; 5301930 RCFW-7.0-35-BV 9/22/2014 9/22/2017; 5312948 RCFW-7.0-35-BV 9/25/2014 9/25/2017; NS5831881 RCFW-7.0-38-75-RB-HLA-091100-BV 4/23/2015 4/23/2018; NS5878399 RCFW-7.0-38-75-RB-HLA-091100-BV 5/12/2015 5/12/2018; NS5890383 RCFW-7.0-38-75-RB-HLA-091100-BV 5/18/2015 5/18/2018; NS5922577 RCFW-7.0-38-75-RB-HLA-091100-BV 6/1/2015 6/1/2018; NS6000260 RCFW-7.0-38-75-RB-HLA-091100-BV 6/30/2015 6/30/2018; NS6091893 RCFW-7.0-38-75-RB-HLA-091100-BV 8/4/2015 8/4/2018; NS6264206 RCFW-7.0-38-75-RB-HLA-091100-BV 10/6/2015 10/6/2018; F4845598 RCFW-8.0-35-BV 2014/03 3/1/2017; NS5312949 RCFW-8.0-35-BV 9/25/2014 9/25/2017; NS5596871 RCFW-8.0-35-BV 1/21/2015 1/21/2018; NS5755064 RCFW-8.0-35-BV 3/26/2015 3/26/2018; NS5793423 RCFW-8.0-35-BV 4/9/2015 4/9/2018; NS5831884 RCFW-8.0-38-75-RB-HLA-091100-BV 4/23/2015 4/23/2018; NS5996958 RCFW-8.0-38-75-RB-HLA-091100-BV 6/29/2015 6/29/2018; NS5996959 RCFW-8.0-38-75-RB-HLA-091100-BV 6/29/2015 6/29/2018; NS6002168 RCFW-8.0-38-75-RB-HLA-091100-BV 7/1/2015 7/1/2018; NS6014785 RCFW-8.0-38-75-RB-HLA-091100-BV 7/7/2015 7/7/2018; NS6014786 RCFW-8.0-38-75-RB-HLA-091100-BV 7/7/2015 7/7/2018; NS6022050 RCFW-8.0-38-75-RB-HLA-091100-BV 7/10/2015 7/10/2018; NS6031799 RCFW-8.0-38-75-RB-HLA-091100-BV 7/14/2015 7/14/2018; NS6083872 RCFW-8.0-38-75-RB-HLA-091100-BV 7/31/2015 7/31/2018; NS6091894 RCFW-8.0-38-75-RB-HLA-091100-BV 8/4/2015 8/4/2018; NS6140704 RCFW-8.0-38-75-RB-HLA-091100-BV 8/20/2015 8/20/2018; NS6225353 RCFW-8.0-38-75-RB-HLA-091100-BV 9/22/2015 9/22/2018; NS6295130 RCFW-8.0-38-75-RB-HLA-091100-BV 10/19/2015 10/19/2018; NS6329426 RCFW-8.0-38-75-RB-HLA-091100-BV 10/28/2015 10/28/2018
- Amount recalled
- 29
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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