# FDA recall Z-2199-2023

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2023-05-18.

## Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)	FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005;   b)	20GX6" FEMORAL ART LINE KIT, Model Number ART1165;   c)	3" RADIAL ARTERIAL LINE KIT, Model Number ART240A;   d)	6" FEMORAL ARTERIAL  LINE KIT, Model Number ART245A;   e)	6" FEMORAL ARTERIAL  LINE KIT, Model Number ART245B;   f)	ARTERIAL LINE BUNDLE, Model Number ART255;   g)	ARTERIAL LINE BUNDLE, Model Number ART560;   h)	A LINE TRAY, Model Number ART690;   i)	ARTERIAL LINE TRAY, Model Number ART840;   j)	18GX6" FEMORAL ART LINE KIT, Model Number ART960;   k)	20Gx3" RADIAL ART LINE KIT, Model Number ART970;   l)	BIOPSY/ASPIRATION TRAY, Model Number BT235A;   m)	PERCUTANEOUS CHEST TUBE KIT, Model Number CHT1825;   n)	PICC INSERTION KIT, Model Number CVI3735;   o)	PICC INSERTION BUNDLE, Model Number CVI4025A;   p)	VASCULAR ACCESS  INSERTION KIT, Model Number CVI4180;   q)	VASCULAR ACCESS INSERT KIT-PEDIATRICS, Model Number CVI4265;   r)	UNIVER

## Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

## Distribution

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

## Key facts

- **Recall number:** Z-2199-2023
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-18
- **Report date:** 2023-07-26

- **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-2199-2023

## Citation

> AI Analytics. FDA recall Z-2199-2023. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-2199-2023. Source: US FDA. Licensed CC0.

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