# FDA recall Z-3109-2026

> **AVID Medical, Inc.** · Class II · device recall initiated 2026-07-14.

## Product

Halyard IV Start Kit Non-Sterile  REF: KRIV26-02

## Reason for recall

Convenience kits contain  BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which  lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.

## Distribution

US Nationwide distribution in the state of NE.

## Key facts

- **Recall number:** Z-3109-2026
- **Recalling firm:** AVID Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-14
- **Report date:** 2026-09-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Toano, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3109-2026

## Citation

> MORVS. FDA recall Z-3109-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/Z-3109-2026. Source: US FDA. Licensed CC0.

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