Reported Dec 25, 2024 · Ongoing
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA…
Medtronic Neurosurgery
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neurosurgery · 4620 North Beach Street · Fort Worth, TX · 76137
Is this the product you have?
- Exacta
- External Drainage and Monitoring System27581 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)
- Lot codes and dates
- Product Number and Description27581 KIT 27581 EXACTA
- W/EDM VCATH 35CM UDI-DI/GTIN code00763000333478
- Lot NumbersEDM 27636 EXACTA
21943473721979266722070367922121399222126213722136861922148248222174414622216380022464355622533642722572701622611126622649096822718811722733207022766961622776229422891403522895782327636
- W/BRAIDED CORD LOCK UDI-DI/GTIN code00763000333492
- Lot NumbersEDM 27666 EXCTA
21939037321963171221979268121988896322047506222052292322115913122126214222152591322174414722208328622227759022265855922302746722316595222330095722408386822428984522443829622527963822533642822611126722636601922649096922718811422733207122795189122808126322857914322878345827666
- W GLUE STPCK GR PT LN UDI-DI/GTIN code00763000333515
- Lot NumbersEDM 27732 EXACTA W/NDL-LS INJ
21939037521960333121979267322010002822023620022023620122028689322028820522029373122029516422029542022029542122031515322031515422113336422130341622168775822186041122208328722216379822220431622265883022281094622302746622305224622307052022307052122316595122325554322408387322408387422434264822459353722523432322563142622611127022611127122636602822651661122651661222651661322713678322738112022738112122763465322766961722773583322777910622823054122885840422885840522895782522901091022910109522918995027732
- ST W/CAP UDI-DI/GTIN code00763000333560
- Lot NumbersEDMS 27785 EXACTA 50ML
21988896422019768622070368022105981822106886722106887922121399322174414822823054222850126627785
- BC NDLESS INJ UDI-DI/GTIN code00763000333607
- Lot NumbersEDMS 27795
21939037421960333221979267622024983222025847222025847322115912722130341722168775922216379922451587822464355322519800322567593322579599622636602722713678422763465722808127122901091627795
- EXACTA 100ML CATH UDI-DI/GTIN code00763000333614
- Lot Numbers219694828 221482480 221922072 27861 EDMS 27861 EXACTA 50ML
- ANTIRFLUX GRNPL UDI-DI/GTIN code00763000333645
- Lot Numbers221687760 227188116 227906187 46700 SYSTEM 46700 EXACTA DISP
- DRAINAGE UDI-DI/GTIN code00763000333690
- Lot NumbersSYSTEM 46705
721 of 721 codes
219317961219317962219317963219317964219317965219318226219318227219318228219318229219351420219351421219351422219351423219351424219351425219352386219390368219390369219390370219390371219434735219434736219434738219434739219434740219434741219434742219434743219434744219434745219435376219481332219481359219481379219481420219481443219481461219511967219512845219513667219513669219513670219528348219528351219528353219543686219543714219603043219603044219603045219603327219603329219656942219656943219656944219656945219683574219683575219738003219738930
- EXACTA DRAINAGE 100ML UDI-DI/GTIN code00763000333706
- Lot Numbers
96 of 96 codes
219390372219395752220051766220156498220236202220244366220453468220461215221158924221262136221525914221827837221916511221916669221922073221952419221952420221955178222277588222277589222595124222595125222601683222629818222658829222695532222724804222742119222810785223130640223165959223833463223833464223833727223878399224277484224277485224277826224277827224303369224303370224303371224303372224342502224438297224438298224471869224471870224515879225198814225198815225234347225234348225271661225271662225336433225336434225375786225375787225412024
- Amount recalled
- 258,367 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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