Arrow International Inc: The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.

Agency Publication Date: September 19, 2018

Affected Products

Product: 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2

23F18B0428

Product: 5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2

23F17K0753, 23F17L0299

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80839

Status: Resolved

Manufacturer: Arrow International Inc

Manufactured In: United States

Units Affected: 2 products (1257 total)

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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

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Medium RiskFDA Device