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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.
Baxter Healthcare recalls 49,200 CONTINU-FLO IV Solution Sets distributed nationwide in the United States. IV sets may leak. Healthcare facilities and patients should stop using the device immediately and follow Baxter's recall instructions.
Wound dressing may have foreign matter on the product.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Baxter Healthcare Corp. recalled 12,720 CLEARLINK SYSTEM CONTINU-FLO IV sets distributed nationwide to healthcare facilities. The devices may leak during use. Hospitals and clinicians should stop using immediately and follow Baxter's recall instructions.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
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 breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Baxter Healthcare recalled 69,936 CLEARLINK System Non_DEHP Extension Sets sold nationwide to hospitals and clinics. The IV extension sets may leak. Healthcare providers should stop using the device and follow Baxter's recall instructions.
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.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
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