# FDA recall Z-2168-2023

> **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)	PORT PACK, Model Number DYNJ64675;  b)	PICC LINE TRAY, Model Number DYNJ64725B;  c)	VEIN OHH, Model Number DYNJ65560C;  d)	PORT PICC TUNNEL PACK, Model Number DYNJ65775;  e)	ENSEMBLE POWER PICC-HEJ-LF, Model Number DYNJ65827;  f)	PICC PACK, Model Number DYNJ65838;  g)	JVL-PACK PICC, Model Number DYNJ66062;  h)	FISTULAGRAM PACK, Model Number DYNJ66259;  i)	VEIN PACK-LF, Model Number DYNJ66271B;  j)	VEIN PACK-LF, Model Number DYNJ66271D;  k)	VASCULAR PACK, Model Number DYNJ66356F;  l)	VENOUS PACK, Model Number DYNJ66499A;  m)	VENOUS PACK, Model Number DYNJ66499B;  n)	VEIN PACK, Model Number DYNJ66743B;  o)	AV FISTULA PACK, Model Number DYNJ66916;  p)	VEIN ABLATION PLUS W CHL, Model Number DYNJ67115A;  q)	PICC INSERTION TRAY, Model Number DYNJ67415;  r)	AFCH CVC INSERTION, Model Number DYNJ67534;  s)	ENS PICC LINE-HEJ-LF, Model Number DYNJ67606;  t)	VEIN TRAY, Model Number DYNJ69012A;  u)	PICC PACK, 

## 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-2168-2023
- **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-2168-2023

## Citation

> AI Analytics. FDA recall Z-2168-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2168-2023. Source: US FDA. Licensed CC0.

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