Z-2495-2020 Class II Terminated
FDA device recall Z-2495-2020 was initiated by Medtronic Perfusion Systems on Aug 8, 2018 and is designated Class II. Reason for recall: Affected products failed a sterilization test. The recall status is terminated (terminated Oct 6, 2020). Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 15, 2020
- Initiation Date
- Aug 8, 2018
- Termination Date
- Oct 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
Extra corporeal circuit with bio-active surface.
Reason for Recall
Affected products failed a sterilization test.
Distribution Pattern
Domestic Distribution only to CA and MI.
Code Information
Lot# 215729283
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2495-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026