Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter
Medical device recall Z-1119-2019. Published in FDA’s Enforcement Report on Apr 17, 2019.
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 Apr 17, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 2 states named in where it went
- 45 eaches total (US) 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?
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
45 eaches total (US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers: US: 71F15J1055 71F15K0223 71F15D1461 71F18A1856 Worldwide: 71F14H0908 71F15K0223 71F16M1878 71F18A0343 71F14J0958 71F15L0155 71F17A0524 71F18A1856 71F14J1954 71F15L1514 71F17A1118 71F18B0295 71F14J1955 71F15M0771 71F17A1119…
Every code shown here, 929 characters
Lot Numbers: US: 71F15J1055 71F15K0223 71F15D1461 71F18A1856 Worldwide: 71F14H0908 71F15K0223 71F16M1878 71F18A0343 71F14J0958 71F15L0155 71F17A0524 71F18A1856 71F14J1954 71F15L1514 71F17A1118 71F18B0295 71F14J1955 71F15M0771 71F17A1119 71F18B3053 71F14K1117 71F16A0286 71F17A2452 71F18C0752 71F14L0040 71F16A1142 71F17C0184 71F18C1686 71F14L0813 71F16B0097 71F17C0408 71F18C2250 71F14M0892 71F16B1126 71F17C2294 71F18C3030 71F14M1389 71F16B2212 71F17C2749 71F18C3042 71F15A0039 71F16C1127 71F17D0329 71F18D2222 71F15D1461 71F16D1063 71F17E1237 71F18E1357 71F15E1320 71F16E0976 71F17E2316 71F18E1753 71F15F1005 71F16F0403 71F17F0829 71F18F2625 71F15F1955 71F16F1512 71F17G1171 71F18G0263 71F15G0461 71F16G0246 71F17G1628 71F18G2183 71F15G1764 71F16H0027 71F17H2043 71F18H0650 71F15H0569 71F16H0595 71F17J0668 71F18H1673 71F15H1347 71F16L0623 71F17L1848 71F18J0116 71F15J0063 71F16L1734 71F17M1416 71F15J1055 71F16M0795 71F17M1978
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.
FL, NC
The states and territories these words name
- Florida
- North Carolina
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 Jan 10, 2019.
- FDA classified it on Apr 10, 2019.
- FDA’s Enforcement Report published it on Apr 17, 2019.
- FDA terminated it on Jun 4, 2020.
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.”
- 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.