FDA Device recall Z-1917-2026
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930…
- FDA Device
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930… 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-1917-2026 |
| 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
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection against catheterrelated infections. Clinical data have not been collected that demonstrate the use of the Arrowg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Reason
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Identifiers
| code_info | Product Code: ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 Batch Number: 33F25M0671 |
|---|
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-1917-2026%22
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