EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Summary
The FDA issued a Class II for EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only by Natus Medical Incorporated. Reason: Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing..
Details
Source
Device Recall
External ID
Z-0635-2024
Action Date
2024-01-10
Status
Ongoing
Category
device
Product Description
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Lot/Code Info: 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
Quantity Affected: 3,336 units
Reason for Recall
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-28
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 84 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Natus Medical Incorporated has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Natus Medical Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Natus Medical Incorporated have FDA actions?
Natus Medical Incorporated has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0635-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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