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# Troubled Zyno Pays $493K over False Claims
- URL: https://www.fdaweb.com/troubled-zyno-pays-493k-over-false-claims/
- Published: 2023-01-09T12:00:00.000Z
- Updated: 2026-09-14T18:11:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153498

Zyno Medical has agreed to pay $493,000 to resolve allegations that it violated the False Claims Act by causing the submission of claims to Medicare involving the intravenous (IV) administration of medication using the firm’s defective IV administration sets.

The settlement resolves allegations that Zyno knowingly distributed defective IV administration sets that were used to deliver chemotherapy and other medications to Medicare beneficiaries, a Justice Department [release ](https://www.justice.gov/opa/pr/medical-device-company-zyno-medical-llc-agrees-pay-nearly-500000-resolve-false-claims-act?ref=fdaweb.com)says. As part of the settlement, Zyno admitted that it knew as early as 2015 that certain 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 2016.

Last July, FDA hit Zyno with a Warning Letter after a 1/29-2/15/2022 inspection found Quality System Regulation violations in the firm’s manufacturing of infusion pumps and associated administration sets ([see earlier story](https://www.fdaweb.com/qs-other-violations-at-zyno-medical/)).