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.
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.
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.
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.
Patients receiving photopheresis treatments who used the recalled kits may be affected. Healthcare providers using the kits are at risk of incorrect sterilization.
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.
Look for the kit lot number on the product to determine if it matches the recalled lot.
The recall was initiated because the kits were shipped in a Dunnage case instead of the correct kit. Dunnage is used during sterilization but is not intended for customer use.
The official recall notice does not specify a remedy or action steps for consumers.
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.
We’ve drafted a message you can send Mallinckrodt to request your refund or repair — edit it as you like.
Subject: Recall Z-0567-2022 — Mallinckrodt Mallinckrodt Hello, I own a Mallinckrodt that is covered by recall Z-0567-2022 from Mallinckrodt. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
