# FDA recall Z-2304-2023

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2023-05-15.

## Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. 16CM CENTRAL LINE BUNDLE, Model Number: STCVC2020;       b. ARTERIAL LINE TRAY, Model Number: ART905;     c. CATHETERLESS INSERTION KIT, Model Number: CVI4510;       d. OR CATHETER INSERTION SETUP PACK, Model Number: ECVC7165A;       e. VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number: STCVC01145B;       f. VANTEX TRIPLE LUMEN BUNDLE, Model Number: STCVC2000;

## Reason for recall

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

## Key facts

- **Recall number:** Z-2304-2023
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-15
- **Report date:** 2023-08-09

- **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-2304-2023

## Citation

> AI Analytics. FDA recall Z-2304-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2304-2023. Source: US FDA. Licensed CC0.

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