Medical device recalls Moderate risk

ARROW INTERNATIONAL, LLC recalls Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531…

Recall date
March 11, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1915-2026
FDA classification
Class II
Brand / firm
ARROW INTERNATIONAL, LLC
Sold / distributed
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.

Why it was recalled

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied

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