—#193527

Product

MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE

FDA product code: MNL — Accessories, Cleaning Brushes, For Endoscope
Device class: Class 1
Medical specialty: Gastroenterology, Urology
Affected lot / code info: DI: (01) 40888277367358; All Envirolite lot numbers which have the following format on individual packaging: YYMMDD X where YY is last 2 digits of Year of production, MM is the number of the month of production, DD is the day of production and X is the leading number of the raw material batch number.

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm initiated the recall by letter on 04/21/2022

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US and Panama

Timeline

Recall initiated: 2022-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193527. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.