Summary
The FDA issued a Class II for Ultracell Wick with 80cc Collection Bag, 20/box by Beaver Visitec International, Inc.. Reason: Device packaging may contain open seals, compromising product sterility..
Details
Source
Device Recall
External ID
Z-1199-2023
Action Date
2023-03-08
Status
Ongoing
Category
device
Product Description
Ultracell Wick with 80cc Collection Bag, 20/box
Lot/Code Info: Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123
Quantity Affected: 4640 units in total
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-20
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beaver Visitec International, Inc. has 182 FDA actions in our database, including 181 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beaver Visitec International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beaver Visitec International, Inc. have FDA actions?
Beaver Visitec International, Inc. has 182 FDA actions in our database, including 181 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1199-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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