Reported Feb 16, 2022 · Ongoing

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

Mallinckrodt Pharmaceuticals Ireland Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mallinckrodt Pharmaceuticals Ireland Ltd · College Business & Technology Park · Dublin 15, N/A · N/A

Is this the product you have?

  • THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Lot codes and dates
  • Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341
Amount recalled
3

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.