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Recall Observatory FDA recall evidence

Device product

External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only

Z-0634-2024

November 28, 2023

Class II

Product summary

Firm
Natus Medical Incorporated
Event
Event 93550
Status
Ongoing
Classification
Class II
Quantity
2,686 units
Official record key
device-enforcement:Z-0634-2024

Official wording

Reason: Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

Code information: UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455

Distribution pattern: 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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Sterility assurance cannot be guaranteed