Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: recall (ARROW INTERNATIONAL, LLC)

Medical deviceClass IIOngoing

Summary: ARROW INTERNATIONAL, LLC is recalling 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: Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured.

What is being recalled

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.

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA. (states named: Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania, Virginia)

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from ARROW INTERNATIONAL, LLC · all medical device recalls · recalls from March 2026

Official FDA record