The firm requested customers to stop using the affected product
San Diego, CA (PRWEB) July 08, 2014
AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Medtronic Duet External Drainage and Monitoring System.
The FDA informed on July 2, that Medtronic Duet External Drainage and Monitoring System is recalled (Class I) because tubing may disconnect and lead to injury. The Medtronic Duet External Drainage and Monitoring System (EDMS) is used to externally drain and monitor cerebrospinal fluid (CSF) and monitor intracranial pressure (ICP) only when trained personnel are present to supervise monitoring and drainage 24-hours a day.
The reason for the recall is that the patient line tubing may separate from the patient line connectors more likely during frequent handling, such as connections where injections or sampling may frequently occur. This may lead to pneumocephalus, infection such as meningitis, ventriculitis, encephalitis and over/under drainage of the CSF that may lead to serious adverse health consequences, including death.
Taking into consideration the latest developments, AttorneyOne.com monitor daily and update the website providing accurate information on all relevant FDA safety alerts. Sean Burke, director of Media Relations at AttorneyOne.com, adds, “We are determined to keep an eye on FDA announcements concerning Medtronic Duet External Drainage and Monitoring System and inform the public. For that reason," he continues, "our focus should squarely fall on investigating these safety alerts and getting the word out.”
As the FDA mentions “On June 9, 2014, the firm sent an Urgent Medical Device Recall letter to their customers. The letter identified the product, the problem, and the actions to be taken.” And the Agency adds “The firm requested customers to stop using the affected product and return all unused devices to Medtronic Neurosurgery.”
AttorneyOne.com has further information on Medtronic Duet External Drainage and Monitoring System at the website including latest major drug and medical products law news.
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