Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0567-2022 — THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

U.S. FDA — Device Enforcement · Ireland · 2021-12-10 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0567-2022
Date of alert
2021-12-10
Country / jurisdiction
Ireland
Risk level
Class II
Risk type
recall
Brand
Mallinckrodt Pharmaceuticals Ireland Ltd
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.