FDA Medical Device Recalls (openFDA)
Natus Medical Incorporated: EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
- Recall number
- Z-0635-2024
- Recalling firm
- Natus Medical Incorporated
- Product
- EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
- Status
- Open, Classified
- Initiated
- 2023-11-28
- Posted
- 2024-01-04
- Terminated
- not on file
- Reason
- Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
- Root cause
- Process change control
- Action
- 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).
- Quantity
- 3,336 units
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K162437"]
- PMA numbers
- not on file
- Product code
- JXG
- Firm FEI
- 2023988
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28