Following the voluntary removal, the FDA deemed the recall Class I, the most serious kind. It affects 52,328 devices in the U.S. in total.
The recall extends to the Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS. InfuTronix initiated the recall in response to 3,698 customer complaints related to its infusion pump system. Complaints from May 2019 to August 2023 identified “several potential product issues,” according to InfuTronix.
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