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Open, Classified

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

FDA Recall Z-0567-2022 · Posted None

Recalling FirmMallinckrodt Pharmaceuticals Ireland Ltd
Recall StatusOpen, Classified
Product CodeLNR
Date Initiated2021-12-10
Product Quantity3

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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