Device product
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Z-0634-2024
Product summary
- 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
Sterility assurance cannot be guaranteed