Arrow International Inc: Medical Device Recall in 2019 - (Recall #: Z-2555-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: 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. The ARROWg+ard¿ 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¿ 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: August 6, 2019

Date Posted: October 2, 2019

Recall Number: Z-2555-2019

Event ID: 83593

Reason for Recall:

Products may contain the incorrect banner card within the kit

Status: Terminated

Product Quantity: 520 eaches

Code Information:

Lot Number: 13F18H0610

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated