FDAClass II · Medical device · Recalled April 29, 2026

Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code recall — ARROW INTERNATIONAL, LLC

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1915-2026
Brand: ARROW INTERNATIONAL
Classification: Class II
Units affected: 5
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code

Companies & origin

Recalling firm location: Morrisville, NC, United States
Firm address: 3015 Carrington Mill Blvd, N/A, 27560-5437

Identifying details (verbatim from the notice)

Product codes / lots: Product Code: ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 Batch Number: 33F25M0011 Product Code: ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 Batch Number: 33F25L0143 Product Code: ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 Batch Number: 33F25L0144 Product Code: ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 Batch Number: 33F25L0145
Distribution: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Firm notified the public via: Letter
FDA event ID: 98618
Recall initiated: March 11, 2026
FDA classified: April 22, 2026
FDA report date: April 29, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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