A recent report by Bloomberg revealed that the medical device giant, Stryker Corp., will stop selling three versions of its Neptune Waste Management System after two people were injured, one fatally, using the devices. The recall has been deemed a “Class I” meaning that it is the most serious of all recalls. Class I recalls are only used for dangerous or defective products that could potentially cause serious health problems or death.
The initial recall, launched in June of this year, was issued after two patients were injured and was meant to alert hospitals and doctors that the waste removal systems should not be connected to passive drainage tubes. In one case, a patient’s passive drainage tube had been connected to a high-powered Neptune 2 system and the patient died.
Then in September the company announced that it would be expanding the recall to include the Neptune 1 Silver, Neptune 2 Ultra and a high-powered Neptune 2 Ultra waste removal systems. The reason is that none of the waste removal systems had proper prior approval by the U.S. Food and Drug Administration (FDA). As such, the devices should never have been marketed until their safety and effectiveness had been assured.
Stryker has taken action to stop all further distribution of the waste removal systems. According to Bloomberg, the company issued the following grave statement to patients: “Customers who do not have an alternative machine available should weigh the risks and benefits of the recalled Neptune devices” and should “request a certificate of medical necessity if they plan to continue using them.”
The FDA has come out to say that the devices were not legally marketed and, as such, should not be used until they have been properly tested and formally approved by the regulatory agency.
The company has also been under fire thanks to a series of recalls for its Rejuvenate and ABG II hip implant devices. Just like the case involving the Neptune waste removal systems; these models were rushed through an abbreviated testing phase that did not permit proper time to rigorously test the devices. Stryker claimed the devices were “substantially similar” to previously approved devices and used that similarity to avoid further scrutiny.
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