Mallinckrodt Pharmaceuticals Ireland Ltd Recall 89383
Description: THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Mallinckrodt Pharmaceuticals Ireland Ltd Recall 89383 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0567-2022 |
| Event ID | 89383 |
| Event Description | THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV. |
| Quantity | 3 |
| Recall 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. |
| Device Classification | 20220216 |
| Device Code Info | Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341 |
| Center Classification Date | 20220207 |
| Recall Initiation Date | 20211210 |
| Recalling Firm | Mallinckrodt Pharmaceuticals Ireland Ltd |
| Similar To |