# FDA recall Z-2322-2023

> **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. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960;     b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970;   c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165;  d. 3" RADIAL ARTERIAL LINE KIT, Model Number: ART240A;     e. 6" FEMORAL ARTERIAL  LINE KIT, Model Number: ART245A, ART245B;     f. A LINE TRAY, Model Number: ART690;     g. A-LINE INSERTION TRAY, Model Number: ART645;     h. AMNIOCENTESIS TRAY, Model Number: MNS8750;     i. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570A;     j. ART LINE TRAY, Model Number: ART865;     k. ARTERIAL LINE BUNDLE, Model Number: ART255, ART560;     l. ARTERIAL LINE TRAY, Model Number: ART840;     m. ARTHROGRAM TRAY, Model Number: SPEC0232;     n. BASIC BIOPSY TRAY, Model Number: DYNDH1534;     o. BEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number: MNS12065;     p. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A;   

## 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-2322-2023
- **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-2322-2023

## Citation

> AI Analytics. FDA recall Z-2322-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2322-2023. Source: US FDA. Licensed CC0.

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