External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Reported: January 10, 2024 Initiated: November 28, 2023 #Z-0634-2024
Product Description
External Drainage System Collection Bag, REF: NT821732C, 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
- 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.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only. Recalled by Natus Medical Incorporated. Units affected: 2,686 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-0634-2024.
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