Warning
ARROW INTERNATIONAL Recalls Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1910-2026Medical Device
ARROW INTERNATIONAL Recalls Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI
ARROW INTERNATIONAL, LLC · Class II — Moderate Risk
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
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a medical device from ARROW INTERNATIONAL, LLC, initiated on March 11, 2026. Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured. This recall covers 85, distributed in AZ, CA, GA, MA, ME, MI, OR, PA, and VA. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects and Arrow International recalls.