Recall Z-0567-2022 ยท LNR System, Photopheresis, Extracorporeal
Mallinckrodt Pharmaceuticals Ireland Ltd
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
| Date | Dec 10, 2021 |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.