The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Recirculator 8.0 Disposable Lavage Kit
- Product Code: 8100
- Lot Numbers: 20021361, 20202106, 20202106, 20018480, 19854186, 20019438, 20018480, 19854186, 19854185, 20202106, 20019438, 19854184, 20202106, 20018480, 20202106, 20018480, 18687686
- Distribution Dates: June 7, 2019 to June 7, 2021
- Devices Recalled in the U.S.: 288
- Date Initiated by Firm: June 4, 2021
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.
Reason for Recall
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.
Who May be Affected
- Health care providers using the Recirculator 8.0 Disposable Lavage Kit with the Hyperthermic Perfusion System
- Patients who are having surgery using the Recirculator 8.0 Disposable Lavage Kit with the Hyperthermic Perfusion System
What to Do
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 to firstname.lastname@example.org.
Customers with questions about this recall should contact Eight Medical International by calling 812-212-2198 Monday through Friday, 8:00 AM to 4:30 PM, Eastern or emailing email@example.com.
- Medical Device Recall Database Entry
- Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices - Letter to Health Care Providers
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.