Mallinckrodt THERAKOS CELLEX Photopheresis Kit Recall: Dunnage Case Shipping Error
Mallinckrodt recalls THERAKOS CELLEX Photopheresis Procedural Kits shipped in a Dunnage case instead of the correct kit. This shipping error may lead to incorrect sterilization.
Lower-risk recall
This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for customer use.
Contact the company
What happened, in plain English
Mallinckrodt is recalling THERAKOS CELLEX Photopheresis Procedural Kits that were shipped in a Dunnage case instead of the correct kit. This error could cause incorrect sterilization during medical procedures. Read more at govinfonow.com/recall/61439-mallinckrodt-therakos-cellex-photopheresis-kit-recall-dunnage-case-shipping-error.
Source Summary by GovInfoNow · govinfonow.com/recall/61439-mallinckrodt-therakos-cellex-photopheresis-kit-recall-dunnage-case-shipping-error · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0567-2022
Cite this page
“Mallinckrodt THERAKOS CELLEX Photopheresis Kit Recall: Dunnage Case Shipping Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61439-mallinckrodt-therakos-cellex-photopheresis-kit-recall-dunnage-case-shipping-error. Based on FDA recall #Z-0567-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0567-2022%22&limit=1).
Why it’s dangerous
Dunnage cases are used during sterilization but are not meant for patient use. The recalled kits were shipped in a Dunnage case instead of the correct kit, which could lead to incorrect sterilization procedures.
Who’s affected
Patients receiving photopheresis treatments who used the recalled kits may be affected. Healthcare providers using the kits are at risk of incorrect sterilization.
How to tell if you have this one
Check for THERAKOS CELLEX Photopheresis Procedural Kits (CLXUSA) shipped in a Dunnage case. The kits were shipped on December 2, 2021, and may have been shipped in place of the correct kit lot.
- Brand
Mallinckrodt- Category
Medical device
What to do — step by step
Check Kit Lot Number
Look for the kit lot number on the product to determine if it matches the recalled lot.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
FDA distribution: “US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Massachusetts, Michigan, New Jersey, New York, North Carolina, Ohio, Tennessee, Texas, Virginia, West Virginia.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product dangerous?
The recall indicates a shipping error that could lead to incorrect sterilization, but the hazard level is low risk as no specific injury mechanism is described.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0567-2022 (December 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0567-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.