Product Safety Recalls

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Unomedical A/S Recall 94217

Description: Neria Soft Infusion Set, Product Code 507302, intravascular administration set

Unomedical A/S Recall 94217 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1544-2024
Event ID94217
Event DescriptionNeria Soft Infusion Set, Product Code 507302, intravascular administration set
Product TypeDevices
DistributionUS Nationwide distribution in the state of Florida.
Quantity10,770 units
Recall ReasonSpecific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.
Device Classification20240424
Device Code InfoUDI/DI 05705244001558, Lot Numbers: 5277396, 5371146
Center Classification Date20240415
Recall Initiation Date20240305
Recalling FirmUnomedical A/S
Initial Notification E-Mail
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