Medtronic Neurosurgery: Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 2

Hazard

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

Details from the source

Reason for recall: Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). Distribution: Worldwide distribution. US nationwide including Puerto Rico; Algeria, Argentina, Australia, Austria, Bahrain, Barbados, Bosnia And Herzegovina, Brunei Darussalam, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, French Guiana, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Honduras, Hong Kong, Iceland, Indone Quantity: 258,367 units Lot/code info: Product Number and Description: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM UDI-DI/GTIN code: 00763000333478 Lot Numbers: 219434737 219792667 220703679 221213992 221262137 221368619 221482482 221744146 222163800 224643556 225336427 225727016 226111266 226490968 227188117 227332070 227669616 227762294 228914035 228957823 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK UDI-DI/GTIN code: 00763000333492 Lot Numbers: 219390373 219631712 219792681 219888963 220475062 220522923 221159131 221262142 221525913 221744147 222083286 222277590 222658559 223027467 223165952 223300957 224083868 224289845 224438296 225279638 225336428 226111267 226366019 226490969 227188114 227332071 227951891 228081263 228579143 228783458 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN UDI-DI/GTIN code: 00763000333515 Lot Numbers: 219390375 219603331 219792673 220100028 220236200 220236201 220286893 220288205 220293731 220295164 220295420 220295421 220315153 220315154 221133364 221303416 221687758 221860411 222083287 222163798 222204316 222658830 222810946 223027466 223052246 223070520 223070521 223165951 223255543 224083873 224083874 224342648 224593537 225234323 225631426 226111270 226111271 226366028 226516611 226516612 226516613 227136783 227381120 227381121 227634653 227669617 227735833 227779106 228230541 228858404 228858405 228957825 229010910 229101095 229189950 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP UDI-DI/GTIN code: 00763000333560 Lot Numbers: 219888964 220197686 220703680 221059818 221068867 221068879 2

UPC codes

00763000333478, 00763000333492, 00763000333515, 00763000333560, 00763000333607, 00763000333614, 00763000333645, 00763000333690, 00763000333706

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.