Class 2 Device Recall CELLEX Procedural Kit

• Date Initiated by Firm: October 04, 2021
• Create Date: November 05, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0212-2022
• Recall Event ID: 88852
• PMA Number: P860003
• Product Classification: System, photopheresis, extracorporeal - Product Code LNR
• Product: THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
• Code Information: LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201
• Recalling Firm/ Manufacturer: Therakos, Inc.; 10 N High St Ste 300; West Chester PA 19380-3014
• For Additional Information Contact: SAME; 908-367-5447
• Manufacturer Reason for Recall: Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
• FDA Determined Cause: Under Investigation by firm
• Action: Mallincrodt intiated recall by telephone on 10/04/21 and by follow-up letter. Letter states reason for recall, health risk and action to take: If you are receiving this notification, you have been identified as a customer who received CELLEX Procedural Kit Lot #K307. Immediately examine your inventory and quarantine the product subject to this recall. Mallinckrodt Pharmaceuticals will provide you with a pre-paid shipping label to return it to the Mallinckrodt Pharmaceuticals warehouse. If you have any questions regarding the return of the recalled product, please contact Mallinckrodt Pharmaceuticals at (877) 566-9466 to receive further instructions. This recall is being carried out to the direct customer level. Your assistance is appreciated. Please complete and return the enclosed response form as soon as possible.
• Quantity in Commerce: Five (5) Cases -3 Kits/Case= 15 Kits
• Distribution: IL
• 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.

• PMA Database: PMAs with Product Code = LNR