LVAD driveline trays recalled over sterilization equipment calibration issues
Medline is recalling 9,720 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
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: Scored 3 under the risk-of-harm criterion: the firm states the calibration issues have the potential to impact the sterility assurance level of products used in sterile procedures, and no injuries are reported.
Plain-English summary
Medline convenience kits are being recalled by Medline Industries, LP, covering LVAD Driveline Trays under model numbers DM1035A and DM1035 and a Central Line Dressing Change Tray under DT8670A.
The record states Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. It states 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 record lists 9,720 units, with model numbers, UDI-DI codes and lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
A sterility assurance level that cannot be relied on carries an infection risk for products used in sterile procedures. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Medline's instructions.
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 — Procedure kit
- Affected units
- 9,720
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.
Part of a larger recall action
This product is one of 42 recalled by Medline Industries, LP 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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