Recall Z-1916-2026— ARROW INTERNATIONAL, LLC

Name: FDA recall Z-1916-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-11

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: MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.. 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

MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.

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.