UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Check against the official notice below — it lists the full affected range.
Neotract Inc. is recalling 18,722 UroLift System devices (model UL400-4) distributed throughout the United States. The devices may fail to properly deliver an implant during deployment procedures.
The affected devices are identified by UDI/DI numbers 00814932020049 and 00814932020001, with multiple lot numbers listed in the recall notice. The recall record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
There is the potential that during implant deployment, the device may not properly deliver a implant.
Reason for recall: There is the potential that during implant deployment, the device may not properly deliver a implant. Distribution: US: 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 Quantity: 18,722 systems Lot/code info: UDI/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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.