Class 2 Device Recall MEDLINE Polyurethane Foam Bedside Cleaning Kit

• Date Initiated by Firm: April 21, 2022
• Create Date: June 02, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1221-2022
• Recall Event ID: 90125
• Product Classification: Accessories, cleaning brushes, for endoscope - Product Code MNL
• Product: MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS
• Code Information: DI: (01) 40888277367396; 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.
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 866-359-1704
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm initiated the recall by letter on 04/21/2022
• Quantity in Commerce: 699 boxes of 50 units
• Distribution: US and Panama
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.