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Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable o...

FDA Device Recall #Z-1388-2017 — Class II — February 1, 2017

Recall Summary

Recall Number Z-1388-2017
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 854

Product Description

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.

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:RCF-4.0(5.0,6.0,7.0,8.0)- / -BV Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 4860671 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.

Other Recalls from Cook Inc.

Recall # Classification Product Date
Z-0388-2022 Class II Flexor Check-Flo Introducer Ansel Modification ... Nov 12, 2021
Z-0387-2022 Class II Flexor Check-Flo Introducer Ansel Modificatio... Nov 12, 2021
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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