Z-0634-2024Class II

External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only

Name: Z-0634-2024 External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Creator: Natus Medical Incorporated
Published: 2023-11-28
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2023-11-28 / Open, Classified / root cause: sterility

FDA source

Natus Medical Incorporated began a recall of External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only on 2023-11-28. FDA classified it as Class II and gives the reason as "Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0634-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-28
Posted: 2024-01-04
Recalling firm: Natus Medical Incorporated
Product: External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Root cause tag: sterility
FDA 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 [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).
Quantity in commerce: 2,686 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.
Product codes and lots: UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0634-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0634-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-04
Z-0635-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-04

Product code JXG

K162437Class IICodman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. / cleared 2016-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)