# FDA recall Z-3299-2024

> **ARROW INTERNATIONAL Inc.** · Class II · device recall initiated 2024-07-26.

## Product

Arrow Arterial Kits and Trays as follows:    (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1;    (2)  Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK;    (3)  Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1;    (4)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS;    (5)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID;    (6)  Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC;     (7)  Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA;    (8)  Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD;    (9)  Arrow

## Reason for recall

Reports have been received regarding open seals on the packaging.

## Distribution

US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC, NY, PA, and WV.  There was government distribution.

## Key facts

- **Recall number:** Z-3299-2024
- **Recalling firm:** ARROW INTERNATIONAL Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-26
- **Report date:** 2024-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3299-2024

## Citation

> AI Analytics. FDA recall Z-3299-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-3299-2024. Source: US FDA. Licensed CC0.

---

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