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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

ARROW INTERNATIONAL Inc.: Arrow ErgoPack PICC Kits Recalled for Incorrect Product Labeling

Agency Publication Date: September 15, 2023
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Summary

Arrow International Inc. is recalling 367 Arrow ErgoPack Pressure Injectable One-Lumen and Two-Lumen PICC kits because the product name and code were incorrectly listed on the lid of the sterile kits. This labeling error means healthcare providers may inadvertently use a device with different specifications than intended for a patient's procedure. These medical devices are catheters used to provide long-term access to a patient’s vascular system for treatments such as fluid delivery or blood sampling.

Risk

The incorrect product name and code on the packaging could lead a medical professional to select and use the wrong catheter for a procedure. This error could result in improper treatment delivery or procedural delays, potentially causing patient harm under certain clinical conditions.

What You Should Do

  1. Identify your kit by checking the packaging for Arrow ErgoPack Pressure Injectable One-Lumen PICC (REF CDC-05541-HPK1A) with Batch/Lot number 13F22J0617.
  2. Check your inventory for Arrow ErgoPack Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet (REF CDC-35552-VPS) with Batch/Lot number 13F22E0359.
  3. Immediately stop using any affected kits and sequester them to prevent accidental use in medical procedures.
  4. Contact Arrow International Inc. at 3015 Carrington Mill Blvd, Morrisville, North Carolina, or call their customer service for specific instructions on returning the mislabeled products.
  5. Healthcare providers should consult with the manufacturer or their facility's risk management department regarding any patients who may have been treated using these specific lots.
  6. For additional information or questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Arrow ErgoPack Pressure Injectable One-Lumen PICC
Model / REF:
REF CDC-05541-HPK1A
Z-2590-2023
Lot Numbers:
13F22J0617
Product: Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet
Model / REF:
REF CDC-35552-VPS
Z-2591-2023
Lot Numbers:
13F22E0359

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92850
Status: Active
Manufacturer: ARROW INTERNATIONAL Inc.
Manufactured In: United States
Units Affected: 2 products (190 units; 177 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.