FDAMay 16, 2025device
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood v...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.
What to do
FDA enforcement status: Ongoing
Brands named
therakos developmenttherakos
UPCs
20705030200003
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAG&L Food Dried Bean Curd Net WT 17.6 OZ (500G) INGREDIENTS: Soybean, Water, Magnesium Chloride as Preservative CONTAINS: Soybean 121C was sterilized at high temperature PRODUCT OF CHINA U.S.A. Distributed By: G&L PRODUCE INC 1140 REVERE AVE SAN FRANCISCO CA 94124 UPC: 69763255602362025-09-16
- FDASteamable by Lidl Chopped Spinach NET WT 12 OZ (340 g) UPC 4 056489 34380 6. Frozen product.2022-01-19
- FDAGiant Eagle, Diced Green Peppers, 10 oz. poly bags and 22# cases, also poly bags and cartons, 12/10 oz. bags per case and bulk 22 lbs. bags2021-11-30
- FDATHERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA2021-10-04
- FDANicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3.2020-09-09
- FDAA&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.2019-09-10
- FDAA&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.2019-09-10
- FDAA&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.2019-09-10
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