The purpose of this letter is to advise you that Medtronic is conducting a voluntary Urgent Medical Device Recall for all serial numbers of the BIO CAL Temperature Controller, Models 370 and 370I. We are requesting BIO CAL users to discontinue use and dispose of BIO CAL devices. No other Medtronic products are affected by this action. In recent years, safety issues have been raised by advanced surgical recall pdf, including FDA, regarding water system quality of temperature controllers, regardless of the manufacturer.
The concern stems from the potential for bacterial growth in the water systems that can be transmitted to patients during surgery, and is likely related to the recommended water system cleaning practices and protocols employed. Medtronic distributed BIO CAL devices to the marketplace between 1989 and 2011. Medtronic has collaborated with regulators to develop a revised cleaning protocol for the BIO CAL devices, but after significant efforts we have been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning protocol will not be developed by Medtronic and it has been determined that the best course of action is to request BIO CAL users to discontinue use and dispose of BIO CAL devices.
Medtronic is recommending that BIO CAL Temperature Controllers Models 370 and 370I no longer be used for clinical procedures. An updated cleaning protocol will not be developed by Medtronic. Dispose of any devices in your possession per your normal equipment obsolescence procedures. Do not resell for clinical use.
For patients who were exposed to a BIO CAL device, there are no recommendations for additional follow-up, physician communication, or a change in patient management beyond routine practice. Acknowledge this Urgent Medical Device Recall by completing the enclosed Customer Confirmation Certificate, then scan and email to RS. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. Medtronic is communicating this information to the appropriate Regulatory authority. We regret any inconvenience this may cause.
We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Sales Representative. Read more about popular Annual Educational Conference topics in the new ACGME blog. We will be performing website maintenance on Wednesday April 18 between 7:30 am-9:30 am Central. You may experience intermittent problems accessing the website during this time. View a video from the American Foundation for Suicide Prevention and Mayo Clinic for ways to recognize signs of depression and stress and how to help. Addressing Clinician Well-Being video discussion with ACGME President and CEO Dr.
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