Medline ultrasound probe cover kits recalled for inadequate seam barriers
Medline probe cover kits used in diagnostic ultrasound procedures may have inadequate barriers at the seams. The recall affects 540 units distributed worldwide between December 2017 and May 2023.
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: FDA Class II recall with no reported illnesses or injuries. The hazard—inadequate seam barriers in sterile probe covers—represents a risk-of-harm medical device where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
Medline Industries is recalling probe cover kits containing sterile ultrasound gel, labeled as CATH LAB PACK with Model Number DYNJ58351A, used during diagnostic ultrasound procedures. The probe covers may have an inadequate barrier at the seams.
The recall affects 540 units distributed worldwide between December 2017 and May 2023. Distribution includes the United States and the following countries: United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. The affected products can be identified by Model Number DYNJ58351A and the UDI/DI codes: UDI/DI (EA) 10888277739390 and UDI/DI (CS) 40888277739391.
An inadequate seam barrier in a sterile medical device used in diagnostic procedures may compromise the intended sterile barrier function during ultrasound examinations.
The recalled product
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB PACK, Model Number DYNJ58351A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- inadequate-barrier
- 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) 10888277739390
- UDI/DI (CS) 40888277739391
Distribution
Distributed nationwide across the United States.
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