← FDA ENFORCEMENT
Z-1910-2026Class II

ARROW INTERNATIONAL, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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
85
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.

Code / lot info

Product code: ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 Batch Number: 33F25J0347

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. 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. Open the enforcement explorer →