Ultracell Wick with 80cc Collection Bag, 20/box
This recall is currently active, issued March 1, 2023. It was issued by Beaver Visitec International, Inc..
- Recall Initiated
- December 20, 2022
- Posted
- March 1, 2023
- Recall Number
- Z-1199-2023
- Quantity
- 4640 units in total
- Firm Location
- City Point Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Device packaging may contain open seals, compromising product sterility.
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
Lot / Code Info
Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123
Root Cause
Process control
Action Taken
A consignee letter was issued to impacted customers on January 18, 2023. The communication advises consignees to immediately examine inventory and quarantine product from impacted lots. If further distribution has occurred, a sub-recall should be initiated. A completed copy of the Business Response Form shall be completed and returned to beavervisitec8978@sedgwick.com.