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Unomedical A/S Recall 93269

Description: VariSoft infusion set, Model Number 1002828

Unomedical A/S Recall 93269 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0233-2024
Event ID93269
Event DescriptionVariSoft infusion set, Model Number 1002828
Product TypeDevices
DistributionUS Nationwide distribution in the state of CA.
Quantity1679 units
Recall ReasonThe 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 from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.hyperglycemia). Diabetic ketoacidosis.
Device Classification20231129
Device Code InfoGTIN 05705244018730, Serial Numbers: 5388367, 5388376; GTIN 05705244018723, Serial Numbers: 5388367. 5388376
Center Classification Date20231120
Recall Initiation Date20231011
Recalling FirmUnomedical A/S
Initial Notification E-Mail
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