Reported Aug 9, 2023 · Ongoing

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB…

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 followinga. CATH LAB PACK
  • Model NumberDYNJ58351A; b. PV CAROTID PACK
  • Model NumberDYNJ63341B
Lot codes and dates

4 of 4 products

Products covered by this recall
Model / numberBarcodesProduct as published
DYNJ58351A
088827773939UPC Number: 088827773939. b.
DYNJ63341B
019348995809UPC Number: 019348995809.
Amount recalled
624 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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, 6:20 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.