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U.S. Department of Health and Human Services

Class 2 Device Recall Natus External Drainage System Collection Bag

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 Class 2 Device Recall Natus External Drainage System Collection Bagsee related information
Date Initiated by FirmNovember 28, 2023
Date PostedJanuary 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0634-2024
Recall Event ID 93550
510(K)NumberK162437 
Product Classification Shunt, central nervous system and components - Product Code JXG
ProductExternal Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Code Information UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455
Recalling Firm/
Manufacturer		 Natus Medical Incorporated
5955 Pacific Center Blvd
San Diego CA 92121-4309
For Additional Information Contactsr. Quality Specialist
858-455-1115
Manufacturer Reason
for Recall		Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
FDA Determined
Cause 2		Process change control
ActionOn 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 in Commerce2,686 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JXG
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