# FDA recall Z-2164-2023

> **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)	MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K;  b)	VEIN SPECIALISTS PACK, Model Number DYNJ53616A;  c)	SUMMIT SKIN AND VEIN PACK, Model Number DYNJ54014B;  d)	VEIN PACK, Model Number DYNJ54153B;  e)	RFD-ENDOVASCULAR OR PACK, Model Number DYNJ54265A;  f)	PEDI EP PACK, Model Number DYNJ54750G;  g)	EL PASO VERICOSE VEIN PACK, Model Number DYNJ54803C;  h)	LEE VEIN PACK, Model Number DYNJ54906B;  i)	HEART FAILURE PK, Model Number DYNJ55528A;  j)	HEART FAILURE PK, Model Number DYNJ55528B;  k)	HEART FAILURE PK, Model Number DYNJ55528C;  l)	ROCKWAY VASCULAR PACK-LF, Model Number DYNJ55757C;  m)	OPEN HEART ANGIO PACK, Model Number DYNJ55836B;  n)	DR NACKMAN VEIN PACK, Model Number DYNJ56235;  o)	KT TAVR PACK, Model Number DYNJ56283D;  p)	KT TAVR PACK, Model Number DYNJ56283F;  q)	VEIN PACK, Model Number DYNJ56724B;  r)	VASCULAR PACK, Model Number DYNJ56791A;  s)	VASCULAR PACK, Model Number DYNJ56791B;

## 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-2164-2023
- **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-2164-2023

## Citation

> AI Analytics. FDA recall Z-2164-2023. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-2164-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*