FDA Device recall Z-1393-2017
TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch by Cook, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1393-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-01 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook |
| Distribution | 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 |
Product
TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions. This device is also intended for injection of radiopaque contrast media for the purpose of angiography.
Reason
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.
Identifiers
| code_info | Catalog Identifier: KCXS-5.0- / -RB-0/0-HC KCXS-5.0- / -RB-0/DAV-HC KCXS-5.0- / -RB-MPB/0-HC KCXS-5.0- / -RB-MPB/DAV…Catalog Identifier: KCXS-5.0- / -RB-0/0-HC KCXS-5.0- / -RB-0/DAV-HC KCXS-5.0- / -RB-MPB/0-HC KCXS-5.0- / -RB-MPB/DAV-HC Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 5062454 KCXS-5.0-35-100-RB-0/0-HC 7/8/2014 7/1/2017; 5136679 KCXS-5.0-35-100-RB-0/0-HC 8/7/2014 8/7/2017; 5197803 KCXS-5.0-35-100-RB-0/0-HC 8/21/2014 8/21/2017; 5219620 KCXS-5.0-35-100-RB-0/0-HC 9/2/2014 9/2/2017; 5263513 KCXS-5.0-35-100-RB-0/0-HC 9/18/2014 9/18/2017; 5263513X KCXS-5.0-35-100-RB-0/0-HC 9/18/2014 9/18/2017; 5306527 KCXS-5.0-35-100-RB-0/0-HC 10/9/2014 10/9/2017; 5380279 KCXS-5.0-35-100-RB-0/0-HC 11/3/2014 11/3/2017; 5491296 KCXS-5.0-35-100-RB-0/0-HC 1/7/2015 1/7/2018; 5628924 KCXS-5.0-35-100-RB-0/0-HC 2/27/2015 2/27/2018; 5710455 KCXS-5.0-35-100-RB-0/0-HC 4/14/2015 4/14/2018; 5768551 KCXS-5.0-35-100-RB-0/0-HC 6/9/2015 6/9/2018; 5785293 KCXS-5.0-35-100-RB-0/0-HC 7/7/2015 7/7/2018; 5785296 KCXS-5.0-35-100-RB-0/0-HC 7/7/2015 7/7/2018; 5832319 KCXS-5.0-35-100-RB-0/0- |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1393-2017%22
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