Medline ultrasound probe covers recalled for inadequate seam barrier
Medline Probe Cover Kits used in diagnostic ultrasound procedures are recalled because probe covers may have an inadequate barrier at the seams, potentially allowing contamination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a potential contamination risk due to an inadequate barrier defect at seam locations. The product comes into contact with patients during diagnostic procedures. Per the rubric, this qualifies as a risk-of-harm product where no injury has yet been reported, resulting in a score of 3.
Plain-English summary
Medline Industries is recalling Probe Cover Kits (Model DT22065) containing sterile ultrasound gel used during diagnostic ultrasound procedures. The probe covers may have an inadequate barrier at the seams.
The defect could allow contamination to bypass the intended barrier protection during ultrasound procedures. No illnesses or injuries have been reported to date.
The recall affects 3,975 units distributed worldwide from December 2017 through May 2023 to the United States and internationally to the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. Healthcare facilities and clinics that received these products should review the recall information and follow Medline's remediation instructions.
The recalled product
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, Model Number DT22065
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- barrier-defect
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- all lots within expiry
- UDI/DI (EA) 10653160326601
- UDI/DI (CS) 40653160326602
Distribution
Distributed nationwide across the United States.
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