# FDA recall Z-1040-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-11-18.

## Product

Medline procedure kits labeled as:    1) Port Access Kit, Reorder number CVI5130;   2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray

## Reason for recall

Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1040-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-18
- **Report date:** 2025-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1040-2025

## Citation

> AI Analytics. FDA recall Z-1040-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1040-2025. Source: US FDA. Licensed CC0.

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