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Lower risk Medical device recall · FDA · Published August 10, 2023

Arrow ErgoPack PICC Kit Recalled for Incorrect Labeling on Lidstock

Arrow recalls ErgoPack Pressure Injectable One-Lumen PICC kits with incorrect labeling on lidstock. Affected kits may have mislabeled product codes, but no safety risk exists.

🇺🇸 FDA recall #Z-2590-2023Medical deviceArrow ›
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Contact the company

Recalling firmARROW INTERNATIONAL Inc.3015 Carrington Mill Blvd · Morrisville, NC 27560-5437
✎ GovInfoNow plain-language explainer

Arrow is recalling a specific PICC catheter kit due to incorrect labeling on the lidstock. This labeling error does not pose a safety risk to users. Read more at govinfonow.com/recall/57491-arrow-ergopack-picc-kit-recalled-for-incorrect-labeling-on-lidstock.

Source Summary by GovInfoNow · govinfonow.com/recall/57491-arrow-ergopack-picc-kit-recalled-for-incorrect-labeling-on-lidstock · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2590-2023

Cite this page

“Arrow ErgoPack PICC Kit Recalled for Incorrect Labeling on Lidstock.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57491-arrow-ergopack-picc-kit-recalled-for-incorrect-labeling-on-lidstock. Based on FDA recall #Z-2590-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2590-2023%22&limit=1).

The FDA announced on August 10, 2023, that Arrow International Inc. is recalling Arrow ErgoPack Pressure Injectable One-Lumen PICC catheters because product codes and names were incorrectly listed on the lidstock of affected kits. The recall involves 190 units distributed nationwide.

How to tell if you have it

  • Brand: Arrow
  • Product: Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
  • Lot number: 13F22J0617

The hazard

The FDA stated the recall was initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

Context

GovInfoNow's records show ARROW INTERNATIONAL Inc. has 52 other recalls on record since June 1, 2017. Other recent recalls include Arrow Arterial Kits and Trays (July 26, 2024), Arrow Ultra 8 IAB Catheter Kit (April 29, 2024), and ARROW QuickFlash Radial Artery Catheter (February 12, 2024). Similar recent recalls of similar products include Arrow PICC Kits Recall: Risk of Serious Injury from Contaminated Medication (April 21, 2026) and Arrow PICC Kits Recall: Risk of Serious Injury from Compromised Sterility (April 21, 2026).

How to tell if you have this one

Check for the batch number 13F22J0617 on the lidstock of Arrow ErgoPack Pressure Injectable One-Lumen PICC kits. The product code and name may be mislabeled on the lidstock.

  • Brand
    Arrow
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-2590-2023Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular; Batch/Lot number 13F22J0617190 units
Z-2591-2023Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter; Batch/Lot number 13F22E0359177 units
Based on the official FDA remedy

What to do — step by step

  1. Check Labeling

    Verify the product code and name on the lidstock of the kit. If they appear incorrect, contact Arrow for guidance.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Aug 10, 202312. FDA classified it Class II: Sep 15, 202323. Published in FDA’s Enforcement Report: Sep 27, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2590-2023 (August 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2590-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA