FDA recall Z-1910-2026

ARROW INTERNATIONAL, LLC · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2026-03-11
Report date
2026-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1910-2026