# FDA recall Z-2162-2023

> **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)	CATH PACK, Model Number DYNJ83105;  b)	TESIO, Model Number DYNJ83251;  c)	ANGIOGRAPHY PACK-LF, Model Number DYNJ83508;  d)	OR ANGIOGRAM PACK-LF, Model Number DYNJ83656;  e)	FERRELL-DUCAN ANGIO, Model Number DYNJ83696;  f)	ANGIO KIT PACK, Model Number DYNJ83746;  g)	M&E ARTERIOGRAM PK, Model Number DYNJ83815;  h)	ANGIOGRAPHY CV RAD PACK, Model Number DYNJ83918;  i)	ANGIO PACK, Model Number DYNJ83936;  j)	ARTERIOGRAM - SUMMIT PACK, Model Number DYNJ84040;  k)	ANGIO PACK, Model Number DYNJ84190;  l)	ANGIO, Model Number DYNJ902507C;  m)	ANGIO, Model Number DYNJ902507D;  n)	ANGIO, Model Number DYNJ905151B;  o)	PACK ANGIOPLASTY CV,8405, Model Number DYNJ906766B;  p)	(13) STC IVC FILTER/ANGIOGRAM, Model Number DYNJ908249A;  q)	OR ANGIOGRAM, Model Number DYNJ909267;  r)	RADIOLOGY PACK #108402-LF, Model Number DYNJVB1000;  s)	HYBRID OR PACK, Model Number SYNJ10303C

## 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-2162-2023
- **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-2162-2023

## Citation

> AI Analytics. FDA recall Z-2162-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2162-2023. Source: US FDA. Licensed CC0.

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