FDA Device recall Z-2029-2014
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device
- FDA Device
- Class II
- terminated
- Published 2014-07-23
On 2014-07-23 the FDA classified a Class II recall of Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device by Terumo Cardiovascular Systems, citing during set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2029-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-14 |
| Published | 2014-07-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Reason
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Identifiers
| code_info | Lot No. RC07, QM03, QN07, and RA09. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2029-2014%22
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