CLASS II ONGOING Device recall · Reported 17 Nov 2021 · FDA Enforcement Report
Cellex Photopheresis Procedural Kit Product recalled by Therakos
Therakos is recalling Cellex Photopheresis Procedural Kit, distributed in Illinois. The recall was initiated on 4 Oct 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0212-2022
- FDA event ID
- 88852
- Recalling firm
- Therakos, West Chester, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Oct 2021
- FDA classified
- 5 Nov 2021
- Reported
- 17 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 4 Oct 2021 | Recall initiated by company | |
| 5 Nov 2021 | Classified by FDA | +32 days |
| 17 Nov 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
Where it was distributed
IL
Questions about this recall
Why was it 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.
Which lots are affected?
LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201
Where was it sold?
IL
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Therakos
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cellex Photopheresis System is a photoimmune therapy recalled | Therakos | Packaging Defects | Nationwide |
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