Class 1 Device Recall MEDLINE

• Date Initiated by Firm: November 15, 2023
• Date Posted: February 25, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1105-2024
• Recall Event ID: 93800
• Product Classification: Dialysis administration kit - Product Code PEV
• Product: MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088
• Code Information: UDI/DI 40193489884501 (case), 10193489884500 (unit), Lot Numbers: 21LBT672, 22BBG831
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 886-359-1704
• Manufacturer Reason for Recall: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
• FDA Determined Cause: Nonconforming Material/Component
• Action: MEDLINE issued an IMMEDIATE ACTION REQUIRED NURSE ASSIST PRODUCT RECALL notice to its consignees on 11/16/2023 via USPS first class mail and email. The notice explained the problem, requested log on to their portal to identify the products and check their inventory so the product could be quarantined. Once Medline receives the completed response form, over-labels will be shipped to the consignee. Medline Industries, LP instructed customers to over-label the convenience kits with a warning label indicating to remove the sodium chloride irrigation or Sterile water and replace from a different sterile supply. Distributors or consignees who further distributed the affected products were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
• Quantity in Commerce: 35 units
• Distribution: Distribution US nationwide including Puerto Rico, Canada, UAE, 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.