Arrow International Inc: Medical Device Recall in 2017 - (Recall #: Z-2333-2017)

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:

1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins

Product Classification:

Class II

Date Initiated: May 9, 2017

Date Posted: June 21, 2017

Recall Number: Z-2333-2017

Event ID: 77232

Reason for Recall:

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

Status: Terminated

Product Quantity: 27,485 untis distributed in U.S., 4,371 units distributed internationally

Code Information:

Material number: CDA-21242-1A, CDA-29803-1A, CDC-21242-1A, CDC-29803-1A, CDC-29903-1A Device Listing D025768

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Canada

Voluntary or Mandated:

Voluntary: Firm initiated