Reported Aug 9, 2023 · Ongoing

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following

MEDLINE INDUSTRIES, LP - Northfield

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following

26 of 26 products

Products covered by this recall
Model / numberProduct as published
ART96018GX6" FEMORAL ART LINE KIT
ART97020Gx3" RADIAL ART LINE KIT
ART116520GX6" FEMORAL ART LINE KIT
ART240A3" RADIAL ARTERIAL LINE KIT
ART245A6" FEMORAL ARTERIAL LINE KIT, , ART245B
ART690A LINE TRAY
ART645A-LINE INSERTION TRAY
MNS8750AMNIOCENTESIS TRAY
DT22570AART LINE SECUREMENT KIT W/LIDOCAINE
ART865ART LINE TRAY
ART255ARTERIAL LINE BUNDLE, , ART560
ART840ARTERIAL LINE TRAY
SPEC0232ARTHROGRAM TRAY
DYNDH1534BASIC BIOPSY TRAY
MNS12065BEDSIDE PIGTAIL THORACOSTOMY PROCEDURE
MNS7695ABEDSIDE PROCEDURE PREP KIT
DYNDH1661BIOPSY TRAY, , MNS8705
BT235ABIOPSY/ASPIRATION TRAY
DYNDH1389ABRST BX Tray
DYNDC2638CATHETER PREP KIT, , DYNDC2638A
Amount recalled
134,514 kits

This recall covers 50 products

The agency filed one notice per product. You are reading one of them; the other 49 are below.

37 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.