Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY,
Pending LLM rewrite. Source: FDA_DEVICE Z-1411-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
The recalled product
- Product
- Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
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) DM1035A
- UDI-DI: 10653160345251(each)
- 00653160345254(case)
- Lot Number: 2025051290
- 2) DM1035A
- Lot Number: 2025031190
- 3) DM1035A
- Lot Number: 2023062390
- 4) DM1035A
- Lot Number: 2023101290
- 5) DM1035A
- Lot Number: 2022030390
- 6) DM1035A
- Lot Number: 2022072590
- 7) DM1035
- UDI-DI: 10653160327752(each)
- 00653160327755(case)
- Lot Number: 2020042290
- 8) DM1035
- Lot Number: 2020052290
Distribution
Distributed nationwide across the United States.
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