The dialyzer caps had been changed from a threaded version to a push on version whereby the user must push the caps firmly onto the dialyzer to securely affix the cap. As users were accustomed to twisting the caps on, there were complaints of caps coming off resulting in dialysate leaks. two (2) of the complaints received in the United States reported a serious injury to the user related to a slip/fall resulting from the fluid leak. As part of CAPA actions by the manufacturer, IFU (F50010927 rev. B) was updated to IFU (F50010927 rev. C) to specify the method for securing the blood port cap to the dialysate port. As part of this recall, the updated IFU instructions will be communicated.
RecallTracker