Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Reported: July 23, 2014 Initiated: April 14, 2014 #Z-2029-2014
Product Description
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, 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.
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- N/A
- Distribution
- Nationwide Distribution
- Location
- Elkton, MD
Frequently Asked Questions
What product was recalled? ▼
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: N/A.
Why was this product recalled? ▼
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 23, 2014. Severity: Moderate. Recall number: Z-2029-2014.
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