EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Reported: January 10, 2024 Initiated: November 28, 2023 #Z-0635-2024
Product Description
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Reason for Recall
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Details
- Recalling Firm
- Natus Medical Incorporated
- Units Affected
- 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.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only. Recalled by Natus Medical Incorporated. Units affected: 3,336 units.
Why was this product recalled? ▼
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 10, 2024. Severity: Moderate. Recall number: Z-0635-2024.
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