Super Arrow-Flex Percutaneous Sheath Introducer Sets
Medical device recall Z-1064-2016. Published in FDA’s Enforcement Report on Mar 16, 2016.
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 16, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 44 states named
- 56,521 units 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?
Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque with Integral Hemostasis Valve/Side Port, 3-way Stopcock and Tissue Dilator 1: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Obturator: 8 Fr. Rx only. The Arrow Percutaneous Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.
56,521 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Material number :CL-07035 Batch #’s: CF0045142 CF0087118 CF0090127 CF0128575 CF1022799 CF1034863 CF1046302 CF1060275 CF1083652 CF2019968 CF2021329 CF2045237 CF2056298 CF2092322 CF2125658 CF3031070 14F13G0157 14F13H0140 14F13K0108…
Every code shown here, 1,993 characters
Material number :CL-07035 Batch #’s: CF0045142 CF0087118 CF0090127 CF0128575 CF1022799 CF1034863 CF1046302 CF1060275 CF1083652 CF2019968 CF2021329 CF2045237 CF2056298 CF2092322 CF2125658 CF3031070 14F13G0157 14F13H0140 14F13K0108 14F13K0334 14F14A0435 14F14B0295 14F14C0449 14F14F0184 14F14F0282 14F14J0055 14F14L0126 14F15A0097 14F15A0473 14F15C0455 14F15C0455 14F15E0083 14F15E0392 14F15G0350 14F15L0009 Material #: CL-07635 Batch #’s: CF0014629 CF0016145 CF0026765 CF0027875 CF0029004 CF0031879 CF0043747 CF0044445 CF0045312 CF0046072 CF0057307 CF0058371 CF0058639 CF0059715 CF0060443 CF0061539 CF0062000 CF0062968 CF0074416 CF0074954 CF0086388 CF0088268 CF0098848 CF0099814 CF0090135 CF0090990 CF0104732 CF0115512 CF0115640 CF0117991 CF0128581 CF0129532 CF1022803 CF1022900 CF1023194 CF1035539 CF1046005 CF1046603 CF1057461 CF1058601 CF1069026 CF1069417 CF1071115 CF1071530 CF1082816 CF1083655 CF1084050 CF1094408 CF1095121 CF1095422 CF1106140 CF1106463 CF1106567 CF1106866 CF1117776 CF1118184 CF2010024 CF2010554 CF2011013 CF2021345 CF2021568 CF2022380 CF2032704 CF2033760 CF2044057 CF2044557 CF2044918 CF2055632 CF2055879 CF2067193 CF2067783 CF2068117 CF2078723 CF2079280 CF2079792 CF2079893 CF2080185 CF2080838 CF2081222 CF2114750 CF2115091 CF2125371 CF2125810 CF3016842 CF3017268 CF3017895 CF3018102 CF3028486 CF3028692 CF3029687 CF3030417 CF3031073 CF3041971 CF3064771 CF3065130 14F13G0058 14F13G0104 14F13G0229 14F13H0292 14F13H0421 14F13J0267 14F13K0066 14F13K0171 14F13L0012 14F13L0105 14F13M0040 14F14A0310 14F14A0420 14F14B0167 14F14B0309 14F14C0077 14F14C0191 14F14D0013 14F14D0155 14F14D0351 14F14D0373 14F14F0230 14F14F0284 14F14G0425 14F14H0028 14F14H0309 14F14J0021 14F14J0098 14F14J0336 14F14K0036 14F14K0099 14F14K0382 14F14L0352 14F14M0121 14F15A0234 14F15A0341 14F15B0076 14F15B0156 14F15B0372 14F15C0066 14F15D0009 14F15D0089 14F15D0183 14F15D0395 14F15E0180 14F15E0393 14F15F0177 14F15F0409 14F15G0052 14F15G0403 14F15H0237 14F15H0400 14F15H0442 14F15J0047 14F15J0128…
FDA’s list runs to 3,992 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.
Nationwide Distribution including AL AR AZ CA CO CT DE FL GA IA ID IL IN KY LA MA MD MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC TN TX UT VA VT WA WI WV
The states and territories these words name
44 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Jan 12, 2016.
- FDA classified it on Mar 7, 2016.
- FDA’s Enforcement Report published it on Mar 16, 2016.
- FDA terminated it on Feb 26, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Arrow International Inc, of Reading, PA.
- 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 3,992 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
-
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.