FDAClass IIMarch 8, 2023

Ultracell Wick with 80cc Collection Bag recall: Sterility Concern

Ultracell Wick with 80cc Collection Bag, 20/box

Why was Ultracell Wick with 80cc Collection Bag recalled?

Device packaging may contain open seals, compromising product sterility.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123

Product
Ultracell Wick with 80cc Collection Bag, 20/box
Recalling firm
Beaver Visitec International, Inc.
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
Recall date
March 8, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls