# FDA recall Z-2161-2023

> **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)	ANGIOGRAPHY PACK, Model Number DYNJ55252C;  b)	CATH LAB PACK, Model Number DYNJ55455A;  c)	CATH LAB 2, Model Number DYNJ55680A;  d)	IR ANGIO TRAY, Model Number DYNJ56038A;  e)	CATH PACK, Model Number DYNJ56547C;  f)	HYBRID, Model Number DYNJ57049G;  g)	HYBRID, Model Number DYNJ57049I;  h)	HYBRID, Model Number DYNJ57049J;  i)	PERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645C;  j)	GENERAL ANGIO PACK, Model Number DYNJ57760C;  k)	ENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792C;  l)	ANGIO PACK, Model Number DYNJ58111D;  m)	ANGIO PACK, Model Number DYNJ58111F;  n)	PORT PACK, Model Number DYNJ58162;  o)	ENSEMBLE ANGIO CEREBRALE-LF, Model Number DYNJ58178B;  p)	PERIPHERAL CATHETER #668236-V, Model Number DYNJ58510A;  q)	OR ANGIO PACK, Model Number DYNJ59184B;  r)	PORT A CATH PACK, Model Number DYNJ59307F;  s)	CATH PACK, Model Number DYNJ59632D;  t)	PACK PERCUTANEOUS ANGIO  CHRG, Model Number DYNJ6011

## 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-2161-2023
- **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-2161-2023

## Citation

> AI Analytics. FDA recall Z-2161-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2161-2023. Source: US FDA. Licensed CC0.

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