FDA Medical Device Recalls (openFDA)
Mallinckrodt Pharmaceuticals Ireland Ltd: THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
- Recall number
- Z-0567-2022
- Recalling firm
- Mallinckrodt Pharmaceuticals Ireland Ltd
- Product
- THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
- Status
- Open, Classified
- Initiated
- 2021-12-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.
- Lot, serial or model codes
- Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341
- 510(k) numbers
- not on file
- PMA numbers
- P860003
- Product code
- LNR
- Firm FEI
- 3013428851
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28