Recall Z-1390-2017
Cook Inc. · initiated February 1, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
Codes / lots: Catalog Identifier: KCFN-4.0(5.0,6.0,7.0)- / -RA-(S)-HC Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 4427564X KCFN-4.0-18-13-RA-HC 8/21/2014 8/21/2017 4427564XX KCFN-4.0-18-13-RA-HC 8/21/2014 8/21/2017 4427564XXX KCFN-4.0-18-13-RA-HC 8/21/2014 8/21/2017 4427566X KCFN-4.0-18-13-RA-HC 2014/03 3/1/2017 4427568X KCFN-4.0-18-13-RA-HC 2014/03 3/1/2017 4610803X KCFN-4.0-18-13-RA-HC 2014/03 3/1/2017 4954615 KCFN-4.0-18-13-RA-HC 6/1/2014 6/1/2017 5087583 KCFN-4.0-18-13-RA-HC 8/1/2014 8/1/2017 5087583X KCFN-4.0-18-13-RA-HC 8/1/2014 8/1/2017 5102705 KCFN-4.0-18-13-RA-HC 8/11/2014 8/11/2017 5102705X KCFN-4.0-18-13-RA-HC 8/11/2014 8/11/2017 5260392 KCFN-4.0-18-13-RA-HC 10/6/2014 10/6/2017 5260392X KCFN-4.0-18-13-RA-HC 10/6/2014 10/6/2017 4427454X KCFN-4.0-18-23-RA-HC 8/21/2014 8/21/2017 4427454XX KCFN-4.0-18-23-RA-HC 8/21/2014 8/21/2017 4427456X KCFN-4.0-18-23-RA-HC 2014/03 3/1/2017 4427458X KCFN-4.0-18-23-RA-HC 2014/03 3/1/2017 4667209X KCFN-4.0-18-23-RA-HC 8/5/2014 8/5/2017 4844427 KCFN-4.0-18-23-RA-HC 2014/04 4/1/2017 4900689 KCFN-4.0-18-23-RA-HC 5/1/2014 5/1/2017 5579987 KCFN-4.0-18-23-RA-HC 2/25/2015 2/25/2018 4427654X KCFN-4.0-18-7-RA-HC 8/8/2014 8/8/2017…
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.
FDA-determined cause: Under Investigation by firm
Action taken
Cook Inc. is initiating a voluntary recall of multiple products following the identification of an increase in reports of blood loss associated with devices using a specific hemostatic valve design referred to as the blue valve or polyisoprene valve. Potential adverse events that may occur if these devices were used in the arterial system (Flexor Radial Access Sets) include delay in procedure and blood loss. If devices were used in the central venous system, adverse events that may occur include delay in procedure, blood loss, or air embolism. The firm is distributing notices via mail courier on 02/01/2017. Customers are being instructed to share the recall notice with appropriate personnel, including down to the user level, within the customer's organization or to any organization where the potentially affected devices have been transferred. 1. Examine inventory immediately to determine if customers have affected product and quarantine affected product(s). 2. Return affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Returned un-affected product will not be credited. 3. Even if customers do not have affected product on hand, customers must still complete the Acknowledgement and Receipt Form and return via fax 812.339.7316 or email to Fieldactionsna@cookmedical.com. 4. Report adverse events to COOK Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email to: customerrelationsna@cookmedical.com. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: Online at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail) Call the FDA at: 1-800-FDA-1088 Effectiveness checks of this recall will be done by response form mailed. All recalled products will be destroyed at the regional distribution warehouses. A cer
Details
- Recall number
- Z-1390-2017
- Initiated
- February 1, 2017
- Terminated
- September 28, 2018
- Product code
- DYB – Introducer, Catheter
- Quantity
- 41,975
- Distribution
- 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…
- Recalling firm
- Cook Inc., Bloomington, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1387-2017 Class II | Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film…Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an… | 02/01/2017Terminated |
| Z-1388-2017 Class II | Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film…Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an… | 02/01/2017Terminated |
| Z-1389-2017 Class II | Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film…Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an… | 02/01/2017Terminated |
| Z-1391-2017 Class II | Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a…Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an… | 02/01/2017Terminated |
| Z-1392-2017 Class II | Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a…Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an… | 02/01/2017Terminated |
| Z-1393-2017 Class II | TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film…Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an… | 02/01/2017Terminated |