Medium RiskFDA Device

Arrow International Inc: Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.

Agency Publication Date: June 27, 2017

Affected Products

Product: Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology

Device Listing # D149129 Material # ASK-45552-RWJ4 PR-45552-HPHNL

Product: Arrow Glide Thru Peel-Away Sheath/Dilator Introducer

Device Listing # D184260 Material # PL-01055

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77604

Status: Resolved

Manufacturer: Arrow International Inc

Manufactured In: United States

Units Affected: 2 products (9,037 units in the U.S. and 4,500 units internationally; 9,037 units in the U.S. and 4,505 Internationally)

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

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