Centurion LVAD Maintenance Kits Recalled for Potential Sterility Failure
Medline Industries is recalling Centurion LVAD maintenance kits and driveline management trays due to sterility concerns in irrigation solution components from Nurse Assist. The solutions may be non-sterile and could pose infection risks.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I medical device recall. FDA Class I is the highest regulatory classification level for medical devices and is categorized as Critical. The recalled components are used in left ventricular assist device driveline care, critical equipment for end-stage heart disease patients.
Plain-English summary
Medline Industries, LP is recalling Centurion kits and trays that were manufactured using irrigation solution components from Nurse Assist. The affected components include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. Nurse Assist initiated this recall due to potential lack of sterility in specific lots, which could result in non-sterile solutions.
These recalled products are used for driveline management and daily maintenance of left ventricular assist devices (LVADs), which are implanted pumps supporting heart function in patients with end-stage heart disease. The recall affects 113,249 units across multiple product variants, each with specific reference numbers and lot codes. Distribution includes the United States, Puerto Rico, Canada, United Arab Emirates, and Panama.
Non-sterile irrigation solutions pose a risk during driveline care procedures. Patients, healthcare providers, and facilities can identify affected inventory using the product reference numbers and lot codes detailed in the FDA recall notice.
The recalled product
- Product
- Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640; c) DAILY DRIVELINE MGMT SYSTEM, REF DM600; d) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; e) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 113,249
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) REF DM405A
- UDI/DI 00653160322217 (case)
- 10653160322214 (unit)
- Lot Numbers: 2022042580
- 2022070580
- 2022071180
- 2022071880
- 2022072580
- 2022080180
- 2023040380
- 2023050180
- 2023073180
- 2023102380
- b) REF DM640
- UDI/DI 00653160289602 (case)
- 10653160289609 (unit)
- Lot Numbers: 2022041390
- c) REF DM600
- UDI/DI 00653160352610 (case)
- 10653160352617 (unit)
Distribution
Part of a larger recall action
This product is one of 49 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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