THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
- Recall Initiated
- December 10, 2021
- Recall Number
- Z-0567-2022
- Quantity
- 3
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
US Nationwide distribution in the states of CA, FL, GA, MA, MI, NC, NJ, NY, OH, TN, TX, VA, WV.
Lot / Code Info
Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341
Root Cause
Under Investigation by firm
Action Taken
On December 10, 2021, the firm initiated phone calls to potentially affected customers. The firm identified the location of the Dunnage Case on the same day, and the Dunnage Case was returned to the recalling firm.