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Neotract Inc Recall 90548

Description: UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

Neotract Inc Recall 90548 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1502-2022
Event ID90548
Event DescriptionUroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Product TypeDevices
DistributionUS: AK AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NY OH OK PA RI SC SD TN TX UT VA VT WI WV OUS: None
Quantity18,722 systems
Recall ReasonThere is the potential that during implant deployment, the device may not properly deliver a implant.
Device Classification20220810
Device Code InfoUDI/DI: 00814932020049 & 00814932020001; Lot #s: 73M2100393 73A2200670 73M2100394 73A2200671 73M2100395 73A2200672 73A2200012 73A2200673 73A2200013 73A2200674 73A2200014 73A2200832 73A2200221 73A2200841 73A2200222 73A2200859 73A2200223 73A2200905 73A2200224 73B2200116 73A2200225 73B2200466 73A2200226 73C2200567 73A2200473 New Lots added as of 08/01/2022: 73A2200834, 73C2200911, and 73C2201163
Center Classification Date20220804
Recall Initiation Date20220624
Recalling FirmNeotract Inc
Initial Notification Letter
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