Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer ...
FDA Device Recall #Z-1389-2017 — Class II — February 1, 2017
Recall Summary
| Recall Number | Z-1389-2017 |
| 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 | 1,589 |
Product Description
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
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: CFM-200 Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 5383334 CFM-200 10/22/2014 10/22/2017; 5413859 CFM-200 11/3/2014 11/3/2017; 5534624 CFM-200 12/22/2014 12/22/2017; 5596858 CFM-200 1/21/2015 1/21/2018; 5596860 CFM-200 1/21/2015 1/21/2018; 5658131 CFM-200 2/16/2015 2/16/2018; 5683532 CFM-200 2/27/2015 2/27/2018; 5683534 CFM-200 2/27/2015 2/27/2018; 5687431 CFM-200 3/2/2015 3/2/2018; 5741270 CFM-200 3/23/2015 3/23/2018; 5781086 CFM-200 4/6/2015 4/6/2018; 5831551 CFM-200 4/23/2015 4/23/2018; 5836503 CFM-200 4/27/2015 4/27/2018; 5864629 CFM-200 5/6/2015 5/6/2018; 5918539 CFM-200 5/29/2015 5/29/2018; 5952200 CFM-200 6/11/2015 6/11/2018; 5971838 CFM-200 6/19/2015 6/19/2018; 6072470 CFM-200 7/28/2015 7/28/2018; 6072479 CFM-200 7/28/2015 7/28/2018; 6165074 CFM-200 8/29/2015 8/29/2018; 6223829 CFM-200 9/22/2015 9/22/2018; 6255406 CFM-200 10/2/2015 10/2/2018; 6255407 CFM-200 10/2/2015 10/2/2018; 6255408 CFM-200 10/2/2015 10/2/2018; 6276169 CFM-200 10/12/2015 10/12/2018; 6278920 CFM-200 10/12/2015 10/12/2018; 6311713 CFM-200 10/23/2015 10/23/2018; 6332089 CFM-200 10/29/2015 10/29/2018; 6360092 CFM-200 11/6/2015 11/6/2018; NS5226487 CFM-200 8/20/2014 8/20/2017; NS5514147 CFM-200 12/12/2014 12/12/2017; NS5658130 CFM-200 2/16/2015 2/16/2018; NS5712801 CFM-200 3/11/2015 3/11/2018; NS5759898 CFM-200 3/30/2015 3/30/2018; NS5864632 CFM-200 5/6/2015 5/6/2018; NS5871863 CFM-200 5/11/2015 5/11/2018; NS5945483 CFM-200 6/9/2015 6/9/2018; NS6091885 CFM-200 8/4/2015 8/4/2018; NS6126832 CFM-200 8/17/2015 8/17/2018; NS6147094 CFM-200 8/24/2015 8/24/2018; NS6360093 CFM-200 11/6/2015 11/6/2018.
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.