Ultracell Wick with 80cc Collection Bag, 20/box
FDA Recall #Z-1199-2023 — Class II — December 20, 2022
Product Description
Ultracell Wick with 80cc Collection Bag, 20/box
Reason for Recall
Device packaging may contain open seals, compromising product sterility.
Recalling Firm
Beaver Visitec International, Inc. — Waltham, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4640 units in total
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated