Recall Z-0212-2022— Therakos, Inc.

Name: FDA recall Z-0212-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-04

Class II · Ongoing

Class II FDA medical device recall by Therakos, Inc., initiated 2021-10-04. FDA's recall record names no specific 510(k) clearance for this event. Product: THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA. Reason: Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury..

Recalling firm: Therakos, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-10-04
Firm location: West Chester, PA, United States

Product description

THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.