Medline probe covers with inadequate seam barrier may allow contamination
Medline is recalling Probe Cover Kits due to inadequate barriers at the seams, which may allow contamination during ultrasound procedures. The recall affects 51,200 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: This is a Class II recall of a medical device with a structural defect (inadequate barrier at seams) that poses a risk of contamination during use. Although no illnesses or injuries have been reported, the risk to patient safety from a failed barrier on a product used in direct patient contact qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling Probe Cover Kits (Model Number DYNDA1219) containing sterile ultrasound gel. The kits are designed to be used during diagnostic ultrasound procedures.
The recall is being issued because the seams of the probe covers may not provide an adequate barrier. This defect could allow contamination during ultrasound procedures, potentially causing cross-contamination between patients or between equipment and patients.
The recall affects 51,200 units that were distributed worldwide, including throughout the United States and to the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. All affected units were distributed between December 2017 and May 2023 and remain within their expiration dates.
The recalled product
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number DYNDA1219
- 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) 10888277283879
- UDI/DI (CS) 40888277283870
Distribution
Distributed nationwide across the United States.
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