PlainRecalls
FDA Devices Moderate Class II Ongoing

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476

Reported: July 26, 2023 Initiated: May 18, 2023 #Z-2155-2023

Product Description

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476

Reason for Recall

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

Details

Units Affected
100 units
Distribution
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 100 units.
Why was this product recalled?
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 26, 2023. Severity: Moderate. Recall number: Z-2155-2023.