Reported Nov 17, 2021 · Ongoing

THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA

Therakos, Inc.

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: Therakos, Inc. · 10 N High St Ste 300 · West Chester, PA · 19380-3014

Is this the product you have?

  • THERAKOS CELLEX Photopheresis
  • Procedural Kit PRODUCT CODECLXUSA
Lot codes and dates
  • LOT #
  • K307 EXPIRATION DATE2023-02-01
  • UDI(01)20705030200003(10)K307(17)230201
Amount recalled
Five (5) Cases -3 Kits/Case= 15 Kits

Where it was sold

Why it was 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.

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, 4:56 PM UTC

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