# FDA recall Z-2160-2023

> **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 DRAPE PACK, Model Number 00-400305R;  b)	ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C;  c)	ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D;  d)	ANGIOGRAM, Model Number DYNJ0149444N;  e)	DIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G;  f)	PICC LINE PACK-LF, Model Number DYNJ0275614F;  g)	ANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M;  h)	ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233V;  i)	ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233W;  j)	ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233X;  k)	ANGIO PACK-LF, Model Number DYNJ0407399P;  l)	SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535AA;  m)	VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121K;  n)	CARDIAC EP PACK-LF, Model Number DYNJ0429185L;  o)	SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0458661C;  p)	LT HEART/ANGIOGRAPHY PACK-LF, Model Number DYNJ0537652AG;  q)	CATH LAB ANGIO PACK-LF, Model Number DYNJ05

## 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-2160-2023
- **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-2160-2023

## Citation

> AI Analytics. FDA recall Z-2160-2023. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-2160-2023. Source: US FDA. Licensed CC0.

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