# FDA recall Z-2194-2023

> **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)	VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320;  b)	CENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A;  c)	TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1490A;  d)	TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1495A;  e)	CENTRAL VENOUS CATHETER BNDLE KIT, Model Number ECVC1725;  f)	INTRODUCER/INTROFLEX BUNDLE KIT (P/S), Model Number ECVC1915;  g)	20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC1970B;  h)	CVC BUNDLE KIT 20CM, Model Number ECVC2001;  i)	16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC2205A;  j)	CVC BUNDLE KIT 16CM, Model Number ECVC2240A;  k)	FIRST HEALTH 16CM QUAD LUMEN KIT, Model Number ECVC2320;  l)	7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC2440B;  m)	16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2555;  n)	20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2560;  o)	FIRST HEALTH 20CM QUAD LUMEN TRAY, Model N

## 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-2194-2023
- **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-2194-2023

## Citation

> AI Analytics. FDA recall Z-2194-2023. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-2194-2023. Source: US FDA. Licensed CC0.

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