Therakos, Inc. THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Brand
Therakos, Inc.
Lot Codes / Batch Numbers
LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201
Products Sold
LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201
Therakos, Inc. is recalling THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA due to Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL
Page updated: Jan 10, 2026