FDA Device recall Z-1914-2026
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)26…
- FDA Device
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)26… by Arrow International, citing due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1914-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-11 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Arrow International |
| Distribution | US |
Product
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 REF ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied.
Reason
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Identifiers
| code_info | Product Code: ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 Batch Number: 33F25L0140 Pr…Product Code: ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 Batch Number: 33F25L0140 Product Code: ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 Batch Number: 33F25L0143 Product Code: ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 Batch Number: 33F25L0144 Product Code: ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 Batch Number: 33F25L0145 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1914-2026%22
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