Arrow International Inc: Medical Device Recall in 2017 - (Recall #: Z-2255-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 20, 2017

Date Posted: June 14, 2017

Recall Number: Z-2255-2017

Event ID: 76937

Reason for Recall:

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.

Status: Terminated

Product Quantity: unknown-firm reports total devices distributed 43,394 eaches

Code Information:

510K # K011761 and Material numbers CDA-21242-1A, CDA-29803-1A, and CDA-29903-1A

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated