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FDAFDA · Food and drugs·Recall number Z-0662-2025

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 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS 27795 EXACTA 100ML CATH 27861 EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL 46700 SYSTEM 46700 EXACTA DISP. DRAINAGE 46705 SYSTEM 46705 EXACTA DRAINAGE 100ML The Exacta external drainage and monitoring system (EDMS) is a system for externally draining and monitoring cerebrospinal fluid (CSF) and monitoring intracranial pressure (ICP).

Published December 25, 2024 · Recall initiated: November 1, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Medtronic Neurosurgery
Distributor
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, Indonesia, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Lao People s Democratic Republic, Latvia, Lebanon, Libya, Malaysia, Malta, Mauritania, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Republic of Tanzania, Thailand, Trinidad And Tobago, Tunisia, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.
Lot
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 221213993 221744148 228230542 228501266 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ UDI-DI/GTIN code: 00763000333607 Lot Numbers: 219390374 219603332 219792676 220249832 220258472 220258473 221159127 221303417 221687759 222163799 224515878 224643553 225198003 225675933 225795996 226366027 227136784 227634657 228081271 229010916 27795 EDMS 27795 EXACTA 100ML CATH UDI-DI/GTIN code: 00763000333614 Lot Numbers: 219694828 221482480 221922072 27861 EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL UDI-DI/GTIN code: 00763000333645 Lot Numbers: 221687760 227188116 227906187 46700 SYSTEM 46700 EXACTA DISP. DRAINAGE UDI-DI/GTIN code: 00763000333690 Lot Numbers: 219317961 219317962 219317963 219317964 219317965 219318226 219318227 219318228 219318229 219351420 219351421 219351422 219351423 219351424 219351425 219352386 219390368 219390369 219390370 219390371 219434735 219434736 219434738 219434739 219434740 219434741 219434742 219434743 219434744 219434745 219435376 219481332 219481359 219481379 219481420 219481443 219481461 219511967 219512845 219513667 219513669 219513670 219528348 219528351 219528353 219543686 219543714 219603043 219603044 219603045 219603327 219603329 219656942 219656943 219656944 219656945 219683574 219683575 219738003 219738930 219742408 219792669 219836483 219837605 219838586 219838587 219838588 219838589 219854730 219854733 219890567 219890568 220105879 220105880 220156494 220156495 220156496 220156497 220171611 220198178 220198179 220279972 220282626 220288204 220295416 220295417 220295418 220313865 220315146 220315147 220315148 220445512 220455469 220522924 220527536 220610537 220610538 220651432 220651433 220703684 220703685 220749667 220749668 220791470 220791471 220836817 220836818 220836928 220883515 220883516 220935797 220935798 220935827 220952095 220964564 220968719 220968720 221034568 221034569 221092006 221099016 221133365 221159141 221213991 221262141 221482531 221526852 221526853 221528497 221569958 221569959 221598133 221598134 221604937 221614446 221614447 221614448 221646710 221648851 221652156 221687227 221687228 221687229 221744155 221777133 221777135 221777136 221796470 221826632 221827836 221873441 221874035 221916510 221916666 221916667 221955180 221955181 221955182 221955183 221955184 221955185 221955226 222083288 222088592 222121365 222125827 222125828 222125829 222141577 222152806 222163790 222163791 222163792 222163793 222163794 222163795 222163796 222163797 222204311 222204312 222204313 222204314 222204315 222240774 222295
Risk classification
Class I
Area (FDA)
device
Country
United States

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