FDAFDA · Food and drugs·Recall number Z-0634-2024
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Published January 10, 2024 · Recall initiated: November 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Natus Medical Incorporated
- Distributor
- 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.
- Lot
- UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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