FDA Enforcement
Class II
Ongoing
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Recall: Z-0634-2024
·
Reported January 10, 2024
Enforcement
- Recall Number
- Z-0634-2024
- Event ID
- 93550
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Natus Medical Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 10, 2024
- Initiation Date
- November 28, 2023
- Classification Date
- January 4, 2024
- Address
- 5955 Pacific Center Blvd, N/A, San Diego, CA, 92121-4309, United States
Description
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Reason
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Code Info
UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455
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.
Quantity
2,686 units