ClearanceBrief
Recall Z-1220-2022 ยท MNL Accessories, Cleaning Brushes, For Endoscope

MEDLINE INDUSTRIES, LP - Northfield

MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS

DateApr 21, 2022
StatusOpen, Classified
ReasonSporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
Root causeUnder Investigation by firm
ActionThe firm initiated the recall by letter on 04/21/2022
Quantity22765 boxes of 50 units
DistributionUS and Panama
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.