Mallinckrodt Pharmaceuticals Ireland Ltd: Medical Device Recall in 2022 - (Recall #: Z-0567-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

Product Classification:

Class II

Date Initiated: December 10, 2021

Date Posted: February 16, 2022

Recall Number: Z-0567-2022

Event ID: 89383

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.

Status: Ongoing

Product Quantity: 3

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.

Voluntary or Mandated:

Voluntary: Firm initiated