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

Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Recall: Incorrect Labeling on

Arrow recalls ErgoPack Pressure Injectable Arrowg+ard Blue Advance kits with incorrect labeling on lidstock. Affected kits have a specific batch number and style. Contact Arrow for details.

🇺🇸 FDA recall #Z-0004-2024Medical deviceArrow ›
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Contact the company

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

What happened, in plain English

Arrow is recalling certain ErgoPack Pressure Injectable Arrowg+ard Blue Advance PICC kits because the product code and name were incorrectly listed on the lidstock. This labeling error means users might receive the wrong product, but it does not pose a safety risk. Read more at govinfonow.com/recall/57492-arrow-ergopack-pressure-injectable-arrowg-ard-blue-advance-recall-incorrect.

Source Summary by GovInfoNow · govinfonow.com/recall/57492-arrow-ergopack-pressure-injectable-arrowg-ard-blue-advance-recall-incorrect · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0004-2024

Cite this page

“Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Recall: Incorrect Labeling on.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57492-arrow-ergopack-pressure-injectable-arrowg-ard-blue-advance-recall-incorrect. Based on FDA recall #Z-0004-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0004-2024%22&limit=1).

Why it’s dangerous

The hazard comes from incorrect product code and name labeling on the lidstock of affected kits. This error means users might receive the wrong product, but it does not cause injury or damage to the device itself.

Who’s affected

Healthcare professionals who use Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance PICC kits are likely affected. Those who received kits with the incorrect labeling on the lidstock are most at risk.

How to tell if you have this one

Check the lidstock of the kit for the product code and name. Affected kits have batch number 13F22G0508 and style REF CDC-45563-TTS.

  • Brand
    Arrow
  • Category
    Medical device
FDA recall event · 4 products

All 4 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 I
  • Status
    Ongoing
  • Distribution
    US
Recall numberProduct, codes & lotsQuantity
Z-0001-2024Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter; Batch/Lot number 33F23B07811173 units
Z-0002-2024Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days; Batch/Lot number 33F23B0723180 units
Z-0003-2024Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days; Batch/Lot number 13F22L0806380 units
Z-0004-2024Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days; Batch/Lot number 13F22G0508172 units
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Labeling

    Inspect the lidstock for the product code and name. If incorrect, contact Arrow for details.

How this recall unfolded

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Aug 10, 202312. FDA classified it Class I: Oct 4, 202323. Published in FDA’s Enforcement Report: Oct 11, 202332023
  1. Firm started the recall
  2. FDA classified it Class I
  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-0004-2024 (August 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0004-2024 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