4FR Single Lumen Pressure Injectable PICC
Medical device recall Z-0127-2016. Published in FDA’s Enforcement Report on Oct 21, 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 Oct 21, 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
- 31590 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?
Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
31590, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Material Numbers: ASK-05041-CHC2 ASK-05041-LM4 ASK-05041-QV ASK-05541-MS3 CA-05041-HP CA-05041-HPX CDC-04041-HPK1A CH-04041-HMA EU-04041-HP EU-05041-HPMSB EU-05541-HP EU-05541-HPMSB EU-24041-HP EU-24041-HPMSB EU-24041-IR EU-25041-HP…
Every code shown here, 1,995 characters
Material Numbers: ASK-05041-CHC2 ASK-05041-LM4 ASK-05041-QV ASK-05541-MS3 CA-05041-HP CA-05041-HPX CDC-04041-HPK1A CH-04041-HMA EU-04041-HP EU-05041-HPMSB EU-05541-HP EU-05541-HPMSB EU-24041-HP EU-24041-HPMSB EU-24041-IR EU-25041-HP EU-25041-HPMSB EU-25041-IR EU-25541-HP EU-25541-HPMSB EU-25541-IR FR-04041 FR-04041-CF FR-05041 FR-05041-CF PR-04041-HPX PR-05041-HP PR-05541-HPX UK-04041-RDE1 UK-04041-THT UK-05041-HPMIN UK-05041-MSB UK-05041-RDE1 UK-05041-THT with Batch Nos. 23F15E0620 23F15A0584 23F14H0964 23F14F1422 23F13J0289 23F13H0832 23F15C2435 23F14L0090 23F14H0848 23F14F0370 23F14A1352 23F13K0761 23F14H0193 23F15C1236 23F14M0484 23F14L0810 23F14K1361 23F14J0415 23F14E1093 23F14B0844 23F15D0881 23F14L0187 23F15F0752 23F15A1857 23F15D0830 23F14H1112 23F14F1497 23F14C1096 23F14C0640 23F14A1238 23F14A1419 23F14L1144 23F14J1513 23F15D0832 23F15F0147 23F15C0303 23F14J0221 23F14F1504 23F14C0643 23F13K0097 23F13H0994 23F13H0013 23F15F0151 23F15C1553 23F15B0400 23F14K1025 23F14H0328 23F14F1505 23F14C0598 23F13K0003 71F14L0736 71F14K1846 71F15B1940 71F13M1092 71F13L0510 71F14A1536 71F14C0247 71F14B1735 71F14F1289 71F14E2029 71F14J1087 71F14K0628 71F14K0081 71F14L0762 71F14L0323 71F14M0678 71F15A0395 71F15B0648 71F15C0214 71F15D0234 71F15D0053 71F15D1075 23F14G1130 23F14F0115 23F14C0576 23F14A1241 23F13K1064 23F13H0034 23F15D1021 23F14D0713 23F14C0575 23F14A1240 23F13K1065 23F13J1118 23F13H0692 71F13G0655 71F13H1053 71F13H0599 71F13H0225 71F13J0124 71F13J1293 71F13K1289 71F13M0785 71F14A1326 71F14B0312 71F14B0879 71F14E1533 71F14E1967 71F14F1290 71F14G0365 71F14F1358 71F14H0351 71F14H0947 71F14J0869 71F14H1396 71F14K0622 71F14K0082 71F14K1332 71F14M0141 71F15A0152 71F15A1289 71F15A1984 71F15B0638 71F15C1137 71F15D0272 71F15D1059 23F14D1125 23F14D0217 23F14B1013 71F15D1630 71F15F1435 71F14J1734 71F14H1167 71F14M0143 71F15B0996 71F15B0224 71F15C0128 71F15D0578 71F15C1592 71F15D1983 71F15E1582 71F15F1737 71F15E1216 71F15D1909 71F14J1735 71F14H1165 71F15A0163 71F15B0228…
FDA’s list runs to 3,434 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, Australia, Canada, and New Zealand.
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 Sep 18, 2015.
- FDA classified it on Oct 15, 2015.
- FDA’s Enforcement Report published it on Oct 21, 2015.
- FDA terminated it on Jun 25, 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.”
- FDA’s list of codes runs to 3,434 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.