Z-0567-2022 Class II Ongoing
FDA device recall Z-0567-2022 was initiated by Mallinckrodt Pharmaceuticals Ireland Ltd on December 10, 2021 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- February 16, 2022
- Initiation Date
- December 10, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
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.
Distribution Pattern
US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.
Code Information
Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341