Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline is recalling Probe Cover Kits (model DYNJ60126B) with an inadequate barrier at the seams that may compromise sterile protection during ultrasound procedures. The kits were 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: This FDA Class II medical device recall involves probe covers with an inadequate barrier at the seams that could compromise sterile protection during diagnostic ultrasound procedures. The potential contamination risk to patients using these covers warrants a High severity rating.
Plain-English summary
Medline Industries is recalling Probe Cover Kits (model DYNJ60126B), labeled as 'PACK ENDO AAA HYBRID CHRG,' that contain sterile ultrasound gel. Each kit contains 25 units and is used during diagnostic ultrasound procedures.
The probe covers in these kits have an inadequate barrier at the seams. This defect could compromise sterile protection during ultrasound procedures.
The affected kits were distributed worldwide from December 2017 through May 2023 to the United States and to United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. All lot numbers within the product's expiration date are included in this recall.
The recalled product
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B
- 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 (2)
- all lots within expiry
- UDI/DI (CS) 40195327118830
Distribution
Distributed nationwide across the United States.
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