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U.S. Department of Health and Human Services

Class 2 Device Recall CELLEX Procedural Kit

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  Class 2 Device Recall CELLEX Procedural Kit see related information
Date Initiated by Firm October 04, 2021
Create Date November 05, 2021
Recall Status1 Open3, 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 2		 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 and Original Applicant = Mallinckrodt Pharmaceuticals Ireland Limited
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