Class 2 Device Recall Medline

• Date Initiated by Firm: December 27, 2022
• Date Posted: February 23, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1162-2023
• Recall Event ID: 91457
• Product Classification: General surgery tray - Product Code LRO
• Product: (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS; (2) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546D, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS.
• Code Information: (1) UDI/DI (01) 40889942055518; Lot numbers 21KBE911, exp. 3/31/2023; 21JBU806, exp. 3/31/2023; 21IBW034, exp. 3/31/2023; 21HBM415, exp. 3/31/2023; 21GBH194, exp. 3/31/2023; 21CBY712, exp. 3/31/2023; 21BBS824, exp. 3/31/2023; 21BBS043, exp. 3/31/2023; 20XBC895, exp. 12/31/2022; 20WBB357, exp. 8/31/2022; 20KBD323, exp. 9/30/2022; and 20JBT517, exp. 12/31/2021. (2) UDI/DI (01) 40195327069286; Lot number 22CBJ633, exp. 12/31/2022.
• 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: The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Recall letters dated 12/27/2022 were issued via email on 12/27/2022 or via U.S. mail for customers who haver not previously used the Medline Recall Portal. The customer was informed of the issue and told that any affected kits found are to be stickered with labels indicating to remove and replace the affected component from a different sterile supply and return the kit to the customer inventory. The remaining components are acceptable for use. If the customer has the affected kits, they are to indicate the quantity on the response and stickers will be sent to them for placement on the kits. The customer is requested to immediately check their stock for the affected item and lot numbers listed on the recall portal and quarantine the product. The customer is to use the website link in the letter to complete the response form. (The website link contains the specific item and lot numbers that are being recalled.) The quantity of affected product in inventory is to be reported on the response form. Upon receipt of the response form, the customer will receive over-labels via FedEx overnight to affix to the affected kits. If the customer is a distributor or the customer has resold or transferred the product to another company or individual, they are to notify their customer of the recall communication. These downstream customers are to return any affected product to the distributor (or to whoever resold/transferred the product) for collection and return to Medline.
• Quantity in Commerce: 720 trays
• Distribution: US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.
• 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.