THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
- Company
- Therakos, Inc.
- Recall Initiated
- October 4, 2021
- Recall Number
- Z-0212-2022
- Quantity
- Five (5) Cases -3 Kits/Case= 15 Kits
- Firm Location
- West Chester, PA
Reason for Recall
Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
Distribution
IL
Lot / Code Info
LOT # K307 EXPIRATION DATE: 2023-02-01 UDI: (01)20705030200003(10)K307(17)230201
Root Cause
Under Investigation by firm
Action Taken
Mallincrodt intiated recall by telephone on 10/04/21 and by follow-up letter. Letter states reason for recall, health risk and action to take: If you are receiving this notification, you have been identified as a customer who received CELLEX Procedural Kit Lot #K307. Immediately examine your inventory and quarantine the product subject to this recall. Mallinckrodt Pharmaceuticals will provide you with a pre-paid shipping label to return it to the Mallinckrodt Pharmaceuticals warehouse. If you have any questions regarding the return of the recalled product, please contact Mallinckrodt Pharmaceuticals at (877) 566-9466 to receive further instructions. This recall is being carried out to the direct customer level. Your assistance is appreciated. Please complete and return the enclosed response form as soon as possible.