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Recall Observatory FDA recall evidence

Device product

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

Z-0567-2022

December 10, 2021

Class II

Product summary

Firm
Mallinckrodt Pharmaceuticals Ireland Ltd
Event
Event 89383
Status
Ongoing
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0567-2022

Official wording

Reason: 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.

Code information: Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.