Dublin 15, N/A, Ireland
Mallinckrodt Pharmaceuticals Ireland Ltd recalls
1 recall recorded since 2018, most recently on 10 December 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 10 December 2021
- 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.
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0567-2022
- THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.