FDA Device recall Z-2255-2017
ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permit…
- FDA Device
- Class II
- terminated
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class II recall of ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permit… by Arrow International, citing arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2255-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-20 |
| Published | 2017-06-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | US |
Product
ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) 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
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
Identifiers
| code_info | 510K # K011761 and Material numbers CDA-21242-1A, CDA-29803-1A, and CDA-29903-1A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2255-2017%22
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