Medline Probe Cover Kits recalled for potential sterility specification failure
Medline is recalling 1,231,480 Probe Cover Kits distributed worldwide due to potential sterility specification failures in the ultrasound gel component.
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 recall involves a sterile medical device with potential specification failures. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in a High (3) severity rating.
Plain-English summary
Medline Industries, LP is recalling Probe Cover Kits containing Turkuaz Ultrasound Gel in six model configurations (DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, and DYNJEX5900). The recalled quantity is 1,231,480 kits.
The labeled sterile ultrasound gel component in these kits has the potential to not meet sterility specifications. The affected kits were distributed worldwide, including throughout the US and to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.
Healthcare facilities and individuals with affected kits should consult the FDA recall notice for specific lot numbers and contact Medline Industries for instructions regarding affected inventory.
The recalled product
- Product
- Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Numbe
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-failure
- non-sterile
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 (20)
- a. Model Number DYNJE5900
- UDI-DI Each: 10884389114124
- Case: 40884389114125
- Lot Numbers: 06920030012
- 06920030021
- 06920040022
- 06920050011
- 06920070011
- 06920080012
- 06920100011
- 06920110011
- 06920120011
- 06921010011
- 06921010022
- 06921020011
- 06921020021
- 06921030021
- 06921030031
- 06921040011
- 06921050011
Distribution
Distributed nationwide across the United States.
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