FDA recall Z-1217-2022

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE

Reason for recall

Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.

Distribution

US and Panama

Key facts

Status
Ongoing
Initiation date
2022-04-21
Report date
2022-06-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1217-2022