PlainRecalls
FDA Devices Moderate Class II Ongoing

Ultracell Wick with 80cc Collection Bag, 20/box

Reported: March 8, 2023 Initiated: December 20, 2022 #Z-1199-2023

Product Description

Ultracell Wick with 80cc Collection Bag, 20/box

Reason for Recall

Device packaging may contain open seals, compromising product sterility.

Details

Units Affected
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
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
Ultracell Wick with 80cc Collection Bag, 20/box. Recalled by Beaver Visitec International, Inc.. Units affected: 4640 units in total.
Why was this product recalled?
Device packaging may contain open seals, compromising product sterility.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 8, 2023. Severity: Moderate. Recall number: Z-1199-2023.