THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Reported: February 16, 2022 Initiated: December 10, 2021 #Z-0567-2022
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.
Details
- Recalling Firm
- Mallinckrodt Pharmaceuticals Ireland Ltd
- Units Affected
- 3
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.
- Location
- Dublin 15, N/A
Frequently Asked Questions
What product was recalled? ▼
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA. Recalled by Mallinckrodt Pharmaceuticals Ireland Ltd. Units affected: 3.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 16, 2022. Severity: Moderate. Recall number: Z-0567-2022.
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