Recall Z-1388-2017
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
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.
Codes / lots: 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…
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-1388-2017
- Initiated
- February 1, 2017
- Terminated
- September 28, 2018
- Product code
- DYB – Introducer, Catheter
- Quantity
- 854
- 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-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-1390-2017 Class II | Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable…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 |