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FDA recall, scope cleaning machine, Chicago personal injury lawyersDoctors and surgeons rely heavily on medical devices to ensure patient safety. Unfortunately, there is an alarming number of defective medical devices out there. When physicians learn the truth, they are often disturbed and upset, but it is the patients who pay the ultimate price—with their health, their wellbeing, and sometimes even their lives. Such may be the case with the FDA’s recent recalls on nearly 2,800 Custom Ultrasonics machines.

Custom Ultrasonics’ Previous Bar from the FDA

Trusted by hospitals and medical clinics throughout the United States, Custom Ultrasonics’ endoscope reprocessing devices are intended to kill the bacteria and microorganisms found on flexible endoscopes after a procedure, enabling safe re-use of the expensive and important medical equipment.

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zimmer knee implant recallZimmer voluntarily started recalling their Persona Trabecular Metal Tibial Plate knee replacement system in March. The Federal Drug Administration (FDA) issued a Class II recall for all makes and sizes. Companies are responsible for providing product liability for any product they produce and sell.

The FDA Class II Recalls are an intermediate level of concern. There is no immediate danger of death or serious injury, but there is still a possibility if the product’s use is continued. There are also still health and safety concerns. The FDA works with the manufacturer to help patients affected by the product recall to ensure the product is taken off the market as soon as possible.

In the case of Zimmer, they started recalling their Persona Trabecular Metal Tibial Plate system on their own, but not fast enough for the FDA. Complaints started increasing concerning implants loosening and causing complications. Over 11,500 devices are affected by the recall. The Persona system is not the first recall Zimmer has experienced. Two other products they have produced in the past have recently been recalled and taken off the market for similar complaints of the devices loosening. How can a company continue to be trusted to produce products if their products continue to be recalled for similar issues among different devices?

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infant medical device recall, Chicago product liability attorneyPhilips Healthcare initially recalled its Gel-E Donut and Squishon 2 medical devices in May 2014 after visible mold was detected on the outer surface of the products. This recall was for devices distributed from July 2012 to December 2013.

As of October 2014, the Food and Drug Administration (FDA) reported a Class I recall issued by the same manufacturing company for the same devices. These gel-filled products are used under supervision in hospitals to support an infant’s head and body. The following models have been recalled:

  • Gel-E Donut 92025-A;
  • Gel-E Donut 92025-B;
  • Gel-E Donut 92025-C; and
  • Squishon 2 91033-2.

The second recall included products manufactured from July 2012 through to August 2014. The defective devices prompted 12 new complaints of visible mold within just four months of the initial recall. Cladosporium and Penicillium Fungi were two of the molds identified, which can cause:

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