Z-0634-2024 Class II Ongoing
FDA device recall Z-0634-2024 was initiated by Natus Medical Incorporated on November 28, 2023 and is designated Class II. Reason for recall: Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. The recall status is ongoing. Affected quantity: 2,686 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 10, 2024
- Initiation Date
- November 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,686 units
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.
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.
Code Information
UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455