Class 2 Device Recall Medline convenience kits

• Date Initiated by Firm: June 06, 2022
• Create Date: July 27, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1471-2022
• Recall Event ID: 90516
• Product Classification: Central venous catheter tray - Product Code OFF
• Product: Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860A
• Code Information: Lot Code: a. Model Number DYNJ36725B, Lot codes: 19UBB149, b. Model Number DYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - SPT; 1170 S Northpoint Blvd; Waukegan IL 60085-6757
• For Additional Information Contact: Kassandra Cotner; 866-775-6072
• Manufacturer Reason for Recall: Kits contain leaking bottles of isopropyl alcohol
• FDA Determined Cause: Under Investigation by firm
• Action: The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations.
• Quantity in Commerce: 288 units
• Distribution: US Nationwide 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.