These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.
Immediate attention
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
Lack of Assurance of Sterility
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 breaches in the sterile barrier packaging, compromising sterility assurance.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Wound dressing may have foreign matter on the product.
Bulk packaged dietary ingredient manufacturer product label does not declare Milk as an allergen ingredient.
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 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.
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.