PICC Kits with Peel-Away Sheath Component
Medical device recall Z-2462-2015. Published in FDA’s Enforcement Report on Sep 2, 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 2, 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
- 52109 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 catheter peel-away component hub tabs may prematurely detach. One injury reported.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
52109, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Codes: ASK-02041-SEH1 CA-05052-HP CDC-34052-VPS EU-05552-HPMSB ASK-04001-DU4 CA-05052-HPX CDC-35041-VPS FR-04041 ASK-04052-AC CDC-02041-MK1A CDC-35052-VPS FR-04041-CF ASK-05041-LM4 CDC-04041-HPK1A CDC-35541-VPS FR-05041…
Every code shown here, 1,999 characters
Product Codes: ASK-02041-SEH1 CA-05052-HP CDC-34052-VPS EU-05552-HPMSB ASK-04001-DU4 CA-05052-HPX CDC-35041-VPS FR-04041 ASK-04052-AC CDC-02041-MK1A CDC-35052-VPS FR-04041-CF ASK-05041-LM4 CDC-04041-HPK1A CDC-35541-VPS FR-05041 ASK-05052-SFL CDC-04052-HPK1A CDC-35552-VPS FR-05041-CF ASK-05541-MS2 CDC-05041-HPK1A EU-04041-HP FR-05541-CF ASK-05541-MS3 CDC-05052-HPK1A EU-04041-HPMSB PI-01451-LS ASK-15552-LM2 CDC-05541-HPK1A EU-04052-HPMSB PI-01451-LS5 ASK-15552-MS3 CDC-05542-PK1A EU-05041-HPMSB PK-01451-WS ASK-35041-JHVA CDC-05552-HPK1A EU-05052-HPMSB PK-01451-WSSP CA-05041-HP CDC-15552-HPK1A EU-05541-HP UK-05041-HPMIN CA-05041-HPX CDC-34041-VPS EU-05541-HPMSB lot numbers: 23F14H0517 23F14J0077 23F15F0662 71F14M0678 71F15A1660 23F14L0941 23F15C2282 23F14H0328 71F15A0395 71F15B1938 23F14B1232 23F14D0456 23F14C0598 71F15C0214 71F15D0235 23F15A1523 23F14C0059 23F14F1505 71F15D0053 71F14L1345 23F14A1779 23F14E1213 23F14K1025 71F15D1075 71F15D1077 23F14G1295 23F14G1470 23F15B0400 23F14C0576 71F15E0455 23F14J0973 23F14H1111 23F14F1507 23F14F0115 71F14K1571 23F14M0791 23F14J0613 23F14M0440 23F14G1130 71F14F1786 23F15A1171 23F15A0149 23F14F0364 23F14F0504 71F14G1690 23F14H0848 23F15D0507 23F14L0838 23F14D0713 71F14F1844 23F14F0370 23F14J1512 23F14H0331 23F14C0575 71F14E2043 23F15C2435 23F15C0302 23F15B0401 23F14D0724 71F14K0639 23F14L0090 23F15B0399 23F15D0938 23F14E1493 71F15B1937 23F14G1072 23F14C1096 23F15D0313 23F14F0716 71F14L0577 23F14M0774 23F14H1112 23F14D0281 23F14M1010 71F14L1347 23F15D0622 23F14C0640 23F14E1325 23F15D1420 71F15A1302 23F14H0920 23F14F1497 23F14G0091 71F14H0351 71F15B0662 23F14J1382 23F15A1857 23F14D0282 71F14H0947 71F15D0681 23F15A0038 23F15D0830 23F14H0498 71F14G0365 71F14J1860 23F15C1236 23F14G1471 23F14H1312 71F14H1396 71F14F1785 23F14E1373 23F14M0038 23F14D0285 71F14J0869 71F15A0300 23F14E1124 23F14J1312 23F14B1144 71F14K0082 71F15C2011 23F14F0441 23F15A1604 23F14G0095 71F14F1358 23F14J0437 23F14G1226 23F15B2002 23F14H1314 71F14K0622 23F14K0406…
FDA’s list runs to 2,977 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.
US Nationwide Distribution 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 25, 2015.
- FDA’s Enforcement Report published it on Sep 2, 2015.
- FDA terminated it on Jun 28, 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 2,977 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.