Medline Convenience Kits recalled due to sterilization equipment calibration issues
Medline Industries is recalling three models of medical trays due to calibration issues with sterilization equipment that may affect sterility assurance. The recall affects LVAD Driveline Trays and Central Line Dressing Change Trays distributed nationwide.
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 involving medical devices used in critical care (LVAD support and central line management) where compromised sterility assurance poses a risk of serious infection or harm. Although no reported illnesses or injuries are stated in the source, the potential impact on sterility of high-risk devices meets the High severity criterion.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits, including LVAD Driveline Trays (Model Numbers DM1035 and DM1035A) and Central Line Dressing Change Trays (Model Number DT8670A). The recall affects approximately 9,720 units distributed nationwide.
Medline has identified calibration issues with the equipment used to sterilize and package these devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration problems have the potential to impact the sterility assurance level of the recalled products.
Patients and healthcare facilities that have received these devices should contact Medline Industries, LP for instructions on replacement or disposition. Affected lot numbers include DM1035 (lots 2020042290, 2020052290, 2020072290, 2020082690), DM1035A (lots 2022030390, 2022072590, 2023062390, 2023101290, 2025031190, 2025051290), and DT8670A (lot 2020051390).
The recalled product
- Product
- Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
- Manufacturer
- Medline Industries, LP
- Hazard
- sterility-assurance
- sterilization-defect
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)
- 1) DM1035
- UDI-DI: 10653160327752(each)
- 653160327755(case)
- Lot Number: 2020042290
- 2) DM1035
- Lot Number: 2020052290
- 3) DM1035
- Lot Number: 2020072290
- 4) DM1035
- Lot Number: 2020082690
- 5) DM1035A
- UDI-DI: 10653160345251(each)
- 653160345254(case)
- Lot Number: 2022030390
- 6) DM1035A
- Lot Number: 2022072590
- 7) DM1035A
- Lot Number: 2023062390
- 8) DM1035A
- Lot Number: 2023101290
Distribution
Distributed nationwide across the United States.