Medline Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline Industries is recalling 1,240 Probe Cover Kits used in diagnostic ultrasound procedures. The covers may have inadequate barriers at the seams, potentially compromising sterility during medical procedures.
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 FDA recall for a medical device with a defective barrier that could compromise sterility during diagnostic procedures. No illnesses or injuries have been reported; the hazard is theoretical, so the score does not exceed 3 per the rubric.
Plain-English summary
Medline Industries, LP is recalling Probe Cover Kits containing sterile ultrasound gel (Model SPEC0130C) used during diagnostic ultrasound procedures. The probe covers may have inadequate barriers at the seams, which could compromise sterility during medical procedures.
Approximately 1,240 units were distributed worldwide between December 2017 and May 2023 to the United States and internationally, including the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. All affected lots are within their expiration dates.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number SPEC0130C
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 1,240
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) 10193489196641
- UDI/DI (CS) 20193489196648
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 52 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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