Recall Z-0567-2022— Mallinckrodt Pharmaceuticals Ireland Ltd
Class II · Ongoing
Class II FDA medical device recall by Mallinckrodt Pharmaceuticals Ireland Ltd, initiated 2021-12-10. FDA's recall record names no specific 510(k) clearance for this event. Product: THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA. 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..
- Recalling firm
- Mallinckrodt Pharmaceuticals Ireland Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-12-10
- Firm location
- Dublin 15, N/A, Ireland
Product description
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.