Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
IV sets may leak.
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
Potential for device to overheat during operation f the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
Lack of Assurance of Sterility
May contained undeclared almond