Z-2028-2014 Class II Terminated
FDA device recall Z-2028-2014 was initiated by Terumo Cardiovascular Systems Corporation on Apr 14, 2014 and is designated Class II. Reason for recall: During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. The recall status is terminated (terminated Sep 7, 2016).
Recall Details
- Product Type
- Devices
- Report Date
- Jul 23, 2014
- Initiation Date
- Apr 14, 2014
- Termination Date
- Sep 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Reason for Recall
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Distribution Pattern
Nationwide Distribution
Code Information
Lot No. RA07, Lot No. QP02
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2028-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026