FDA Medical Device Recalls (openFDA)
Therakos, Inc.: THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
- Recall number
- Z-0212-2022
- Recalling firm
- Therakos, Inc.
- Product
- THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
- Status
- Open, Classified
- Initiated
- 2021-10-04
- Posted
- not on file
- Terminated
- not on file
- Reason
- Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
- Root cause
- Under Investigation by firm
- Action
- Mallincrodt intiated recall by telephone on 10/04/21 and by follow-up letter. Letter states reason for recall, health risk and action to take: If you are receiving this notification, you have been identified as a customer who received CELLEX Procedural Kit Lot #K307. Immediately examine your inventory and quarantine the product subject to this recall. Mallinckrodt Pharmaceuticals will provide you with a pre-paid shipping label to return it to the Mallinckrodt Pharmaceuticals warehouse. If you have any questions regarding the return of the recalled product, please contact Mallinckrodt Pharmaceuticals at (877) 566-9466 to receive further instructions. This recall is being carried out to the direct customer level. Your assistance is appreciated. Please complete and return the enclosed response form as soon as possible.
- Quantity
- Five (5) Cases -3 Kits/Case= 15 Kits
- Distribution
- IL
- Lot, serial or model codes
- LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201
- 510(k) numbers
- not on file
- PMA numbers
- ["P860003"]
- Product code
- LNR
- Firm FEI
- 2523595
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
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