# FDA recall Z-2181-2023

> **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)	BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755;  b)	VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4;  c)	ULTRASOUND PIV BUNDLE, Model Number IV8635D;  d)	ULTRASOUND GUIDED PIV KIT, Model Number IVS3300;  e)	ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3485A;  f)	EPIV PROCEDURE TRAY, Model Number IVS3825;  g)	ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3840A;  h)	RADIOLOGY TRAY, Model Number MNS11625;  i)	BEDSIDE PROCEDURE PREP KIT, Model Number MNS7695A;  j)	NGHS EVOR ANGIO PACK, Model Number NG410A;  k)	PICC INSERT KIT-LESS THAN 3 FR, Model Number PHS41739A;  l)	RADIOLOGY SPECIALS PACK, Model Number PHS479840M;  m)	HYBRID OR PACK, Model Number SYNJ10303B;  n)	TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500A;  o)	TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500B;  p)	VC PROCEDURE KIT, Model Number VC-PK

## 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-2181-2023
- **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-2181-2023

## Citation

> AI Analytics. FDA recall Z-2181-2023. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-2181-2023. Source: US FDA. Licensed CC0.

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