CELLEX recallZ-0212-2022 · Therakos, Inc. · initiated Oct 4, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Therakos, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Mallincrodt intiated recall by telephone on 10/04/21 and by follow-up letter. Letter states reason for recall, health risk and action to take: If you are receiving this notification, you have been identified as a customer who received CELLEX Procedural Kit Lot #K307. Immediately examine your inventory and quarantine the product subject to this recall. Mallinckrodt Pharmaceuticals will provide you with a pre-paid shipping label to return it to the Mallinckrodt Pharmaceuticals warehouse. If you have any questions regarding the return of the recalled product, please contact Mallinckrodt Pharmaceuticals at (877) 566-9466 to receive further instructions. This recall is being carried out to the direct customer level. Your assistance is appreciated. Please complete and return the enclosed response form as soon as possible.
Recall details
- Recall number
- Z-0212-2022
- Status
- Open, Classified
- Initiated by the company
- Oct 4, 2021
- Recalling firm
- Therakos, Inc.
- Quantity
- Five (5) Cases -3 Kits/Case= 15 Kits
- Product code
- LNR
- FDA submissions
- P860003
- Distribution
- IL
Product description
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Code information (models, lots, serial numbers)
LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CELLEX CLXUSATherakos LLC · SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL2 recalls564 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under P860003 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CELLEX CLXSP-ITherakos LLC · SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL23 reports
- CELLEX CLXCC-ITherakos LLC · SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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