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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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Critical RiskFDA Device
Medical Devices/Surgical Equipment

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

Agency Publication Date: October 5, 2023
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Summary

Arrow International Inc. is recalling approximately 1,905 medical kits, including Arrow ErgoPack and Pressure Injectable Arrowg+ard catheters, because the product name and code on the kit lid are incorrect. This labeling error means the physical contents of the package do not match the description on the outside, which could lead medical professionals to use the wrong device during a procedure. If you are a healthcare provider, check your inventory for the specific lot numbers affected; if you are a patient, your healthcare provider will manage any concerns regarding equipment used during your treatment. Consumers should contact Arrow International for instructions on returning or replacing these kits.

Risk

The incorrect labels could cause a healthcare provider to select and use an inappropriate catheter for a patient's specific medical needs. This mismatch poses a risk of procedural delays or medical complications if the device does not perform as expected for the intended treatment.

What You Should Do

  1. Identify the affected products by checking for 'Arrow ErgoPack' or 'Pressure Injectable Arrowg+ard' kits with the following reference numbers: CDC-45552-VPS2, CDC-42854-PCN1A, CDC-45854-P1A, and CDC-45563-TTS.
  2. Check your supply for the following specific lot numbers: 33F23B0781, 33F23B0723, 13F22L0806, and 13F22G0508.
  3. If you identify any of these kits in your inventory, stop using them immediately and set them aside to prevent accidental use.
  4. Contact Arrow International Inc. at their headquarters in Morrisville, North Carolina, or refer to the firm's notification letter for detailed instructions on how to return the affected kits and obtain replacements.
  5. If you are a patient and believe one of these devices was used during a recent procedure, contact your healthcare provider for further guidance.
  6. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

📋Other Action

Firm-initiated recall via notification letter.

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

Affected Products

Product: Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet
Model / REF:
CDC-45552-VPS2
Lot Numbers:
33F23B0781
Product: Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC
Model / REF:
CDC-42854-PCN1A
Lot Numbers:
33F23B0723
Product: Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC
Model / REF:
CDC-45854-P1A
Lot Numbers:
13F22L0806
Product: Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet
Model / REF:
CDC-45563-TTS
Lot Numbers:
13F22G0508

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93014
Status: Active
Manufacturer: ARROW INTERNATIONAL Inc.
Sold By: Hospitals; Medical Supply Distributors
Manufactured In: United States
Units Affected: 4 products (1173 units; 180 units; 380 units; 172 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.