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EDS 3 CSF External Drainage System, REF: NT821731C… recallZ-0635-2024 · Natus Medical Incorporated · initiated Nov 28, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Natus Medical Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

FDA root cause category: Process change control

What the company is doing

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 [email protected]. You will receive shipping instructions from [email protected] 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).

Recall details

Recall number
Z-0635-2024
Status
Open, Classified
Initiated by the company
Nov 28, 2023
Posted by the FDA
Jan 4, 2024
Recalling firm
Natus Medical Incorporated
Quantity
3,336 units
Product code
JXG
FDA submissions
K162437
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.

Product description

EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

4 devices cleared under K162437 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93550).

Sources and updates

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