FDA Device

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

Hazard

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.

What You Should Do

Remedy

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.

Products

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Brand
Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park Blanchardstown Road North Dublin
UPC
Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341

Units Affected

3