Device product
Ultracell Wick with 80cc Collection Bag, 20/box
Z-1199-2023
Product summary
- Event
- Event 91488
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4640 units in total
- Official record key
device-enforcement:Z-1199-2023
Official wording
Reason: Device packaging may contain open seals, compromising product sterility.
Code information: Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123
Distribution pattern: US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa
Derived failure modes
-
Sterility assurance
packaging may contain open seals, compromising product sterility