Reported Jul 26, 2023 · Ongoing

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model…

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?

  • Medline Probe Cover Kits containing sterile Ultrasound Gel
  • Labeled as the followingSTERILE SET FOR IMPLANT-LF, Model Number OST011F
Lot codes and dates
  • all lots within expiry, distributed from Medline
  • between December 2017 - May 2023
    • Model Number OST011F
    • UDI/DI (EA) 10195327091347
    • UDI/DI (CS) 40195327091348
Amount recalled
1130 units

This recall covers 53 products

The agency filed one notice per product. You are reading one of them; the other 52 are below.

40 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

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, 5:42 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.