Natus Medical Incorporated EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Brand
Natus Medical Incorporated
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI: 00382830050555/ Lot #: 1FX0004588937 1FX0004588938 1FX0004588939 1FX0004663828 1FX0004663825 1FX0004663826 1FX0004663824 1FX0004663827 1FX0004857869 1FX0004857871 1FX0004663829 1FX0004663830 1FX0004857870 1FX0004763454 1FX0004833126 1FX0004833140 1FX0004833139 1FX0004857872 1FX0004857873 1FX0004833127 1FX0004833136 1FX0004763455 1FX0004763460 1FX0004763463 1FX0004763464 1FX0004763462 1FX0004763461 1FX0004763459 1FX0004857877 1FX0004857875 1FX0004857874 1FX0004763457 1FX0004857876 1FX0004763465 1FX0004763456 1FX0004833141 1FX0004763458 1FX0004857882 1FX0004857881 1FX0004857880 1FX0004857878 1FX0004857879 1FX0004857886 1FX0004857884 1FX0004857885 1FX0004857887 1FX0004857888 1FX0004857886 1FX0004857883 1FX0004857889
Natus Medical Incorporated is recalling EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only due to Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Recommended Action
Per FDA guidance
On November 28, 2023, Natus issued a "Urgent Medical Device Recall" Notification to affected consignees via USPS. Natus asked consignees to take the following actions: 1. Immediately cease use of the affected System and quarantine any inventory until you receive the shipping instructions from Natus to return any System(s). 2) Please complete the enclosed form and return to FCA@Natus.com. You will receive shipping instructions from FCA@Natus.com 3) Adverse reactions or quality problems experienced with the use of the System should be reported to Natus and the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. " Complete and submit the report Online at www.fda.gov/medwatch/report.htm " Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 4) Replacement System(s) will be made available to you at no cost. Natus Technical Service will be in contact with you shortly to arrange for the provision of replacement System(s).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026