FDA recall Z-0723-2023

ConvaTec, Inc · Class II · device

Product

ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive

Reason for recall

ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2022-11-15
Report date
2022-12-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Greensboro, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0723-2023