Recall Z-1910-2026— ARROW INTERNATIONAL, LLC
Class II · Ongoing
Class II FDA medical device recall by ARROW INTERNATIONAL, LLC, initiated 2026-03-11. FDA's recall record names no specific 510(k) clearance for this event. 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: Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured.
- Recalling firm
- ARROW INTERNATIONAL, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-11
- Firm location
- Morrisville, NC, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.