Arrow International, Inc
Medical device recall Z-2489-2015. Published in FDA’s Enforcement Report on Sep 9, 2015.
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 Sep 9, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 92902 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?
saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
92902, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Material Nos.: ASK-04001-DU4 ASK-04001-DU5 ASK-04001-DU6 ASK-04001-DU6 ASK-04001-DU7 ASK-04001-DU8 ASK-35052-JHVA1 ASK-45041-JHVA CDC-44041-VPS CDC-35063-VPS CDC-35541-VPS CDC-35552-VPS CDC-35563-VPS CDC-44041-VPS CDC-45541-VPS VPS7220B…
Every code shown here, 1,999 characters
Material Nos.: ASK-04001-DU4 ASK-04001-DU5 ASK-04001-DU6 ASK-04001-DU6 ASK-04001-DU7 ASK-04001-DU8 ASK-35052-JHVA1 ASK-45041-JHVA CDC-44041-VPS CDC-35063-VPS CDC-35541-VPS CDC-35552-VPS CDC-35563-VPS CDC-44041-VPS CDC-45541-VPS VPS7220B CDC-34041-VPS CDC-34052-VPS CDC-34063-VPS CDC-35041-VPS CDC-35041-VPS CDC-35052-VPS CDC-35063-VPS ASK-04001-DU5 CDC-45041-VPS ASK-04001-UOC ASK-35041-JHVA ASK-35052-JHVA CDC-34041-VPS VPS7220B VPS7220B VPS7220B VPS7220B Batch Nos.: 23F14A1779 23F14D0281 23F14M0072 23F14D1271 23F14G0101 23F14G1295 23F14E1325 23F15A1407 23F14F0406 23F15B1012 23F14J0973 23F14G0091 23F15B1630 23F14F0782 RF3053214 23F14M0791 23F14K1260 RF3052236 23F14J1421 23F13M0751 23F13L0144 23F14L0635 RF3052644 23F14K1255 23F14D0332 23F14B1160 23F15B1628 RF3064510 23F14M0026 23F14G0107 23F14D0759 RF3042008 23F14A0375 23F14A1189 23F14J1433 23F14F1092 23F13M0589 23F14A1493 23F14B1128 23F15A0122 23F14G0916 23F14A0451 23F14B0740 23F14C0473 RF3053218 23F14H0046 23F14A1495 23F14B1120 23F14D0308 23F14A1277 23F14J1319 23F14B0056 23F14C0463 23F14J1391 23F14D0378 23F14K1292 23F14B0742 23F14D0286 23F14K1472 23F14F0284 23F15A1551 23F14D0282 23F14E1261 23F14A0448 23F14H0408 23F14K1060 23F14C0728 23F14E1469 23F14A1534 23F14K1258 23F15C1225 23F14H1312 23F14E1262 23F14B0744 23F15A0563 23F15C1226 23F14H0498 23F14G0096 23F14C0476 V1302008 23F14G1091 23F15A0120 23F14H0510 23F14D0314 19F13H0023 23F14J1134 23F15A1191 23F14H1254 23F14F0780 19F13H0022 23F14M1083 23F14A1207 23F14J1390 23F14F1273 19F13K0008 23F15E0418 23F14A1207 23F14K0677 23F14H0512 19F13K0007 23F14C0738 23F14D0284 23F14K1216 23F14K1473 19F13J0012 23F14H0301 23F14G0094 23F14K1243 23F14L0940 19F13K0006 23F14C0740 23F14H1313 23F14L0608 23F13K1266 19F13L0009 23F14F1347 RF3041482 23F14L0969 23F14A1267 19F13K0009 23F14H0885 23F14A1274 23F15A0347 23F14C0459 19F13K0005 23F15B1858 23F14B1144 23F14L0986 23F14D0322 19F13J0014 23F15B1861 23F14D0285 RF3015350 23F14F0782 19F13L0010 23F13L0293 23F14G0095 23F13K1165 23F14H1315 19F13J0013…
FDA’s list runs to 3,219 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 nationwide and Internationally to Canada.
These words name no state.
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.
The words say it went outside the United States too.
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 Jul 30, 2015.
- FDA classified it on Aug 31, 2015.
- FDA’s Enforcement Report published it on Sep 9, 2015.
- 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 3,219 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.