Z-1910-2026 Class II Ongoing

Recalled by ARROW INTERNATIONAL, LLC — Morrisville, NC

FDA device recall Z-1910-2026 was initiated by ARROW INTERNATIONAL, LLC on March 11, 2026 and is designated Class II. Reason for recall: Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured The recall status is ongoing. Affected quantity: 85.

Recall Details

Product Type
Devices
Report Date
April 29, 2026
Initiation Date
March 11, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
85

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.

Reason for Recall

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

Distribution Pattern

U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.

Code Information

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