Ultracell recallZ-1199-2023 · Beaver Visitec International, Inc. · initiated Dec 20, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beaver Visitec International, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Device packaging may contain open seals, compromising product sterility.
FDA root cause category: Process control
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-1199-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 20, 2022
- Posted by the FDA
- Mar 1, 2023
- Recalling firm
- Beaver Visitec International, Inc.
- Quantity
- 4640 units in total
- Product code
- HOZ
- FDA submissions
- K920354
- 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
Product description
Ultracell Wick with 80cc Collection Bag, 20/box
Code information (models, lots, serial numbers)
Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ultracell 40430Beaver-Visitec International, Inc. · Sponge, ophthalmic1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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