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U.S. Department of Health and Human Services

Class 2 Device Recall Therakos Cellex Photopheresis Procedural Kit

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  Class 2 Device Recall Therakos Cellex Photopheresis Procedural Kit see related information
Date Initiated by Firm December 10, 2021
Create Date February 07, 2022
Recall Status1 Open3, Classified
Recall Number Z-0567-2022
Recall Event ID 89383
PMA Number P860003 
Product Classification System, photopheresis, extracorporeal - Product Code LNR
Product THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Code Information Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341
Recalling Firm/
Manufacturer		 Mallinckrodt Pharmaceuticals Ireland Ltd
College Business & Technology Park
Blanchardstown Road North
Dublin 15 Ireland
For Additional Information Contact Mallinkrodt Pharmaceuticals
877-5669466
Manufacturer Reason
for Recall		 This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for customer use.
FDA Determined
Cause 2		 Under Investigation by firm
Action On December 10, 2021, the firm initiated phone calls to potentially affected customers. The firm identified the location of the Dunnage Case on the same day, and the Dunnage Case was returned to the recalling firm.
Quantity in Commerce 3
Distribution US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.
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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