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Open, Classified

THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

FDA Recall Z-0212-2022 · Posted None

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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