FDA recall Z-1199-2023

Product

Ultracell Wick with 80cc Collection Bag, 20/box

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

Key facts

Status

Ongoing

Initiation date

2022-12-20

Report date

2023-03-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1199-2023