← FDA ENFORCEMENT
Z-1917-2026Class II

ARROW INTERNATIONAL, LLC

Recalling firm
ARROW INTERNATIONAL, LLC
Product type
Device
Status
Ongoing
Report date
2026-04-29
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Firm state
NC
Product quantity
95
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Product description

Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection against catheterrelated infections. Clinical data have not been collected that demonstrate the use of the Arrowg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

Code / lot info

Product Code: ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 Batch Number: 33F25M0671

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.