The Recall Desk
HighFDA (Devices)·Z-1015-2023·Announced 2023-02-01

Medical Device Manufacturer Recalls VAD Drive Kits With Expired Component

Medline Industries is recalling 1,050 kits of Centurion Medical Products Silver Antimicrobial VAD Drive due to expired components. Affected kits were distributed across New York, Indiana, Florida, New Jersey, and Illinois.

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: FDA Class II recall of a critical medical device with an identified concrete defect. While no illnesses or injuries have been reported, an expired component in a ventricular assist device creates a risk of device malfunction or improper function.

Plain-English summary

Medline Industries, LP is recalling 1,050 kits of the Centurion Medical Products Silver Antimicrobial VAD Drive (Reference DT18760, UDI/DI 10653160274841) because the kits contained expired components. The affected kits carry Lot Number 22ABO498 and were distributed across the United States to facilities in New York, Indiana, Florida, New Jersey, and Illinois.

The FDA classified this as a Class II recall. An expired component in a ventricular assist device drive could result in device malfunction or failure to operate as intended.

The recalled product

Product
CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ventricular Assist Device
Hazard
  • expired-component
  • device-malfunction-risk

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 (2)

  • UDI/DI 10653160274841
  • Lot Numbers 22ABO498

Distribution

Distributed nationwide across the United States.

Related recalls

Same category