FDA MedWatch - Recirculator 8.0 Disposable Lavage Kits by Eight Medical International:

Class I Recall - Due to Potential Exposure to High Levels of Aluminum

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Recirculator 8.0 Disposable Lavage Kits by Eight Medical International: Class I Recall - Due to Potential Exposure to High Levels of Aluminum AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: Eight Medical is recalling the Recirculator 8.0 Disposable Lavage Kit because the disposable heating element within the kit may release aluminum into the fluid during warming therapy. When the fluid circulates through the patient's body, the patient can be exposed to high levels of aluminum, which can be toxic and cause serious adverse events including death. There have been no complaints, injuries, or deaths reported for this issue. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The Recirculator 8.0 Disposable Lavage Kit is used with the company's Hyperthermic Perfusion System. The disposable lavage kit allows the perfusion system to circulate warm, sterile solution inside a patient's chest (thoracic) or abdominal (peritoneal) cavity to reach a target temperature during surgery. RECOMMENDATIONS: On June 7, 2021, Eight Medical International sent an Urgent Medical Device Recall notification letter to customers by email and mail recommending the following actions: Inspect inventory and quarantine impacted product. Remove and destroy the instructions for use when the disposable kit containing the instructions is opened. Replace those instructions with an updated set of instructions for use, which were attached to the notification letter. Attach a laminated card (provided with the letter) directly on the fluid warmer device. Continue to use the updated instructions for use until the company provides kits with corrected instructions. Complete and return a response form provided with the letter. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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