# FDA recall Z-2163-2023

> **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.	NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q;  b.	PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I;  c.	BAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I;  d.	ENDOVASCULAR CDS, Model Number CDS983394I;  e.	ENDOVASCULAR CDS, Model Number CDS983394J;  f.	ENDOVASCULAR CDS, Model Number CDS983394K;  g.	OPEN HEART CDS, Model Number CDS983513F;  h.	OPEN HEART ANESTHESIA PACK, Model Number CDS983849D;  i.	OPEN HEART ANESTHESIA PACK, Model Number CDS983849F;  j.	VNUS, Model Number CDS984292I;  k.	OPEN HEART CDS, Model Number CDS984355G;  l.	BEDSIDE PICC CDS, Model Number CDS984642;  m.	VASCULAR, Model Number CDS984764G;  n.	OPEN HEART A, Model Number CDS985105O;  o.	VASCULAR, Model Number CDS985355D;  p.	VASCULAR, Model Number CDS985355F;  q.	ECMO KIT, Model Number CVI4955;  r.	KIT CARDIAC CSICU ADULT ECMO, Model Number DYKMBNDL21;  s.	VASCULAR ACCESS PROCEDURE KIT, Model Number DYNDA252

## 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-2163-2023
- **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-2163-2023

## Citation

> AI Analytics. FDA recall Z-2163-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2163-2023. Source: US FDA. Licensed CC0.

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