Recall Z-1915-2026— ARROW INTERNATIONAL, LLC
Class II · Ongoing
Class II FDA medical device recall by ARROW INTERNATIONAL, LLC, initiated 2026-03-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured.
- Recalling firm
- ARROW INTERNATIONAL, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-11
- Firm location
- Morrisville, NC, United States
Product 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
Reason for recall
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Data sourced from openFDA. This site is unofficial and independent of the FDA.