VariSoft infusion set, Model Number 1002828

Recall Insight

This FDA Devices action (record #Z-0233-2024) was formally reported on November 29, 2023, with the manufacturer initiating the action on October 11, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Unomedical A/S is listed as the recalling firm, operating out of LEJRE, N/A. Federal records indicate 1679 units units are affected.

The documented reason for this recall is: The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily … Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.