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Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterili...

FDA Device Recall #Z-1392-2017 — Class II — February 1, 2017

Recall Summary

Recall Number Z-1392-2017
Classification Class II — Moderate risk
Date Initiated February 1, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cook Inc.
Location Bloomington, IN
Product Type Devices
Quantity 29

Product Description

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

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to Canada, Armenia, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Spain, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Kenya, Kuwait, Lithuania, Mauritius, Netherlands, Norway, Oman, Poland, Reunion, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom VA/DOD: Yes

Lot / Code Information

Catalog Identifier:RCFW-7.0(8.0)-38-75-RB-HLA-091100-BV Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 4826254 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.

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Z-0414-2022 Class II Skinny Needle with Chiba Tip. RPN 090010, 09001... Oct 13, 2021
Z-0222-2022 Class II Transseptal Needle, Trocar. RPN TSNC-18-71.0, T... Oct 8, 2021
Z-0223-2022 Class II Transseptal Needle with Catheter. RPN TSN-17-75... Oct 8, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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