THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
FDA Recall Z-0212-2022 · Posted None
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Recalling FirmTherakos, Inc.
Recall StatusOpen, Classified
Product CodeLNR
Date Initiated2021-10-04
Product QuantityFive (5) Cases -3 Kits/Case= 15 Kits
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
IL
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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