Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park Blanchardstown Road North Dublin THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Brand
Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park Blanchardstown Road North Dublin
Lot Codes / Batch Numbers
Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341
Products Sold
Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341
Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park Blanchardstown Road North Dublin is recalling THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA due to 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 i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On December 10, 2021, the firm initiated phone calls to potentially affected customers. The firm identified the location of the Dunnage Case on the same day, and the Dunnage Case was returned to the recalling firm.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026