TriForce Peripheral Crossing Set, Individual product is
Medical device recall Z-1393-2017. Published in FDA’s Enforcement Report on Mar 8, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 8, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 46 states named in where it went
- 1,875 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
1,875, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,993 characters
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-HC 7/10/2015 7/10/2018; 5832319X KCXS-5.0-35-100-RB-0/0-HC 7/10/2015 7/10/2018; 5899897 KCXS-5.0-35-100-RB-0/0-HC 7/10/2015 7/10/2018; 6113669 KCXS-5.0-35-100-RB-0/0-HC 12/2/2015 12/2/2018; 6113672 KCXS-5.0-35-100-RB-0/0-HC 12/2/2015 12/2/2018; NS5216411 KCXS-5.0-35-100-RB-0/0-HC 9/2/2014 9/2/2017; NS5585693 KCXS-5.0-35-100-RB-0/0-HC 2/5/2015 2/5/2018; NS5765432 KCXS-5.0-35-100-RB-0/0-HC 5/26/2015 5/26/2018; NS5968268 KCXS-5.0-35-100-RB-0/0-HC 7/21/2015 7/21/2018; NS6084219 KCXS-5.0-35-100-RB-0/0-HC 8/11/2015 8/11/2018; 5129805 KCXS-5.0-35-100-RB-0/DAV-HC 7/30/2014 7/30/2017; 5248809 KCXS-5.0-35-100-RB-0/DAV-HC 9/12/2014 9/12/2017; 5380252 KCXS-5.0-35-100-RB-0/DAV-HC 11/10/2014 11/10/2017; 5508027 KCXS-5.0-35-100-RB-0/DAV-HC 1/14/2015 1/14/2018; 5628913 KCXS-5.0-35-100-RB-0/DAV-HC 2/27/2015 2/27/2018; 5720805 KCXS-5.0-35-100-RB-0/DAV-HC 7/7/2015 7/7/2018; 5785299 KCXS-5.0-35-100-RB-0/DAV-HC 4/21/2015 4/21/2018; 5785302 KCXS-5.0-35-100-RB-0/DAV-HC 7/7/2015 7/7/2018; 5867734 KCXS-5.0-35-100-RB-0/DAV-HC…
FDA’s list runs to 7,185 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
46 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 1, 2017.
- FDA classified it on Mar 2, 2017.
- FDA’s Enforcement Report published it on Mar 8, 2017.
- FDA terminated it on Sep 28, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cook Inc., of Bloomington, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 7,185 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.