Micropuncture Check-Flo Performer Introducer Set, Individual product is
Medical device recall Z-1391-2017. 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
- 778 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?
Micropuncture 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
778, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog Identifier: RCFN-4.0(5.0,6.0, 7.0)- / -MPIS-NT-BV Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 4726168 RCFN-4.0-18-MPIS-NT-BV 2014/01 1/1/2017; 4734774 RCFN-4.0-18-MPIS-NT-BV 2014/01 1/1/2017; 4785752…
Every code shown here, 1,997 characters
Catalog Identifier: RCFN-4.0(5.0,6.0, 7.0)- / -MPIS-NT-BV Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 4726168 RCFN-4.0-18-MPIS-NT-BV 2014/01 1/1/2017; 4734774 RCFN-4.0-18-MPIS-NT-BV 2014/01 1/1/2017; 4785752 RCFN-4.0-18-MPIS-NT-BV 2014/02 2/1/2017; 4941369 RCFN-4.0-18-MPIS-NT-BV 2014/05 5/1/2017; 4941371 RCFN-4.0-18-MPIS-NT-BV 5/1/2014 5/1/2017; 4941373 RCFN-4.0-18-MPIS-NT-BV 5/1/2014 5/1/2017; 4951551 RCFN-4.0-18-MPIS-NT-BV 2014/05 5/1/2017; 4951553 RCFN-4.0-18-MPIS-NT-BV 5/1/2014 5/1/2017; 5045963 RCFN-4.0-18-MPIS-NT-BV 6/1/2014 6/1/2017; 5115985 RCFN-4.0-18-MPIS-NT-BV 7/23/2014 7/23/2017; 5115987 RCFN-4.0-18-MPIS-NT-BV 7/30/2014 7/30/2017; 5129780 RCFN-4.0-18-MPIS-NT-BV 7/28/2014 7/28/2017; 5129782 RCFN-4.0-18-MPIS-NT-BV 7/28/2014 7/28/2017; 5201283 RCFN-4.0-18-MPIS-NT-BV 8/28/2014 8/28/2017; 5319456 RCFN-4.0-18-MPIS-NT-BV 10/21/2014 10/21/2017; 5347620 RCFN-4.0-18-MPIS-NT-BV 10/20/2014 10/20/2017; 5347622 RCFN-4.0-18-MPIS-NT-BV 11/6/2014 11/6/2017; 6091299 RCFN-4.0-18-MPIS-NT-BV 8/30/2015 8/30/2018; 6091301 RCFN-4.0-18-MPIS-NT-BV 8/19/2015 8/19/2018; 6091303 RCFN-4.0-18-MPIS-NT-BV 8/21/2015 8/21/2018; 6091305 RCFN-4.0-18-MPIS-NT-BV 8/24/2015 8/24/2018; 6131402 RCFN-4.0-18-MPIS-NT-BV 9/8/2015 9/8/2018; 5045952 RCFN-5.0-18-MPIS-NT-BV 6/1/2014 6/1/2017; 5187958 RCFN-5.0-18-MPIS-NT-BV 8/14/2014 8/14/2017; 5201279 RCFN-5.0-18-MPIS-NT-BV 9/16/2014 9/16/2017; 5237325 RCFN-5.0-18-MPIS-NT-BV 9/4/2014 9/4/2017; 5335434 RCFN-5.0-18-MPIS-NT-BV 10/24/2014 10/24/2017; 5402692 RCFN-5.0-18-MPIS-NT-BV 11/26/2014 11/26/2017; 5573051 RCFN-5.0-18-MPIS-NT-BV 1/28/2015 1/28/2018; 5589611 RCFN-5.0-18-MPIS-NT-BV 2/10/2015 2/10/2018; NS5233872 RCFN-5.0-18-MPIS-NT-BV 9/4/2014 9/4/2017; NS6043627 RCFN-5.0-18-MPIS-NT-BV 8/4/2015 8/4/2018; NS6374382 RCFN-5.0-18-MPIS-NT-BV 11/29/2015 11/29/2018; 4938690 RCFN-6.0-18-MPIS-NT-BV 2014/05 5/1/2017; NS5350917 RCFN-6.0-18-MPIS-NT-BV 10/23/2014 10/23/2017; NS5402799 RCFN-6.0-18-MPIS-NT-BV 11/14/2014 11/14/2017; NS5493803…
FDA’s list runs to 2,312 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 2,312 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.