FDA DevicesClass II
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)108019022203...
Published: April 29, 2026Recall ID: Z-1910-2026Category: devicesCountry: US
Reason for Recall / Hazard
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Morrisville |
| State | NC |
| Event id | 98618 |
| Address 1 | 3015 Carrington Mill Blvd |
| Address 2 | N/A |
| Code info | Product code: ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 Batch Number: 33F25J0347 |
| Postal code | 27560-5437 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 85 |
| Reason for recall | Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260311 |
| Initial firm notification | Letter |
| Center classification date | 20260422 |
Overview
- Recalling FirmARROW INTERNATIONAL, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.