Zyno Medical LLC (Zyno), a medical device manufacturer headquartered in Massachusetts, has agreed to pay $493,140 to resolve allegations that it violated the False Claims Act by causing the submission of claims to Medicare in connection with the intravenous (IV) administration of medication using devices Zyno knew were materially defective.
The settlement announced today resolves allegations that Zyno knowingly distributed defective IV administration sets that were used to deliver controlled dosages of chemotherapy and other medications to Medicare beneficiaries. As part of the settlement, Zyno has admitted that it knew as early as Nov. 5, 2015 that certain of its administration sets, sold for use with its Z-800 series of IV infusion pumps, were defective and that the defect caused leaks during the infusion of medication. Zyno has further admitted that it did not institute a recall of the defective administration sets until July 29, 2016 and, in fact, continued to sell additional affected administration sets into commerce for a period of time.
“Medicare patients who need chemotherapy or other medication administered intravenously should not have to worry about whether the devices used for their treatment will deliver the intended dosage,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “We will pursue appropriate relief when health care providers, including medical device manufacturers, knowingly put the...
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