Z-1199-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2023
- Initiation Date
- December 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4640 units in total
Product Description
Ultracell Wick with 80cc Collection Bag, 20/box
Reason for Recall
Device packaging may contain open seals, compromising product sterility.
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
Code Information
Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123