FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1910-2026
·
Reported April 29, 2026
Enforcement
- Recall Number
- Z-1910-2026
- Event ID
- 98618
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ARROW INTERNATIONAL, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 29, 2026
- Initiation Date
- March 11, 2026
- Classification Date
- April 22, 2026
- Address
- 3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States
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
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
Code Info
Product code: ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 Batch Number: 33F25J0347
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Quantity
85