Medical device recalls Moderate risk

Therakos, Inc. recalls THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

Recall date
October 4, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0212-2022
FDA classification
Class II
Brand / firm
Therakos, Inc.
Sold / distributed
IL

Why it was recalled

Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

Get recall alerts

Free email alert whenever Therakos, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Therakos, Inc.