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
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