Medline Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline is recalling Probe Cover Kits with sterile Ultrasound Gel because the probe covers may have an inadequate barrier at the seams. These diagnostic ultrasound kits are distributed worldwide.
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 used during diagnostic ultrasound procedures. The inadequate seam barrier poses a risk of harm through potential contamination; however, no illnesses or injuries have been reported, making it a score 3 per the rubric.
Plain-English summary
Medline Industries is recalling Probe Cover Kits containing sterile Ultrasound Gel (Models CDS840214P and DYNJ82725). The probe covers may have an inadequate barrier at the seams, which could potentially compromise their protective function during diagnostic ultrasound procedures.
The recall involves 316 units distributed worldwide between December 2017 and May 2023. The affected kits have been distributed to customers in the United States and internationally, including the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.
Medialine has not reported any illnesses or injuries associated with these products. Customers who have received these kits should contact Medline Industries or consult the FDA recall notice (Z-2189-2023) for guidance on returns or replacement.
The recalled product
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214P; b) ABLATION PACK, Model Number DYNJ82725
- 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 (6)
- all lots within expiry
- UDI/DI (EA) 10193489443196
- UDI/DI (CS) 40193489443197
- b) Model Number DYNJ82725
- UDI/DI (EA) 10195327207380
- UDI/DI (CS) 40195327207381
Distribution
Distributed nationwide across the United States.
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