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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

Arrow International Inc: Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.

Agency Publication Date: February 13, 2018
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Affected Products

Product: ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter

Lot/Batch Numbers: 23F17A0038, 23F17A0040, 23F16M0059.

Lot Numbers:
Numbers
Product: ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.

Lot/Batch Numbers: 13F16A0089, 13F16A0180, 13F17B0290, 23F16F0614.

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78964
Status: Resolved
Manufacturer: Arrow International Inc
Manufactured In: United States
Units Affected: 2 products (2691 total)

Were You Affected by This Recall?

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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.