Recall Z-0212-2022 ยท LNR System, Photopheresis, Extracorporeal
Therakos, Inc.
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
| Date | Oct 4, 2021 |
| Status | Open, Classified |
| 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 Pharmaceu |
| Quantity | Five (5) Cases -3 Kits/Case= 15 Kits |
| Distribution | IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.