FDA recall Z-2614-2021

ConvaTec, Inc · Class II · device

Product

DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)

Reason for recall

Primary packaging labeling may be incorrect.

Distribution

Distribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA

Key facts

Status
Ongoing
Initiation date
2021-08-20
Report date
2021-10-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Greensboro, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2614-2021