# FDA recall Z-2555-2019

> **Arrow International Inc** · Class II · device recall initiated 2019-08-06.

## Product

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.

## Reason for recall

Products may contain the incorrect banner card within the kit

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2555-2019
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-06
- **Report date:** 2019-10-02
- **Termination date:** 2020-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reading, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2555-2019

## Citation

> AI Analytics. FDA recall Z-2555-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2555-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*