FDAClass IIJuly 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound recall

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, Model Number DT22065

Why was Medline Probe Cover Kits containing sterile Ultrasound recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number DT22065, UDI/DI (EA) 10653160326601, UDI/DI (CS) 40653160326602

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, Model Number DT22065
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
3975 units
Distribution
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Recall date
July 26, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls