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U.S. Department of Health and Human Services

Class 2 Device Recall Tandem Life

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  Class 2 Device Recall Tandem Life see related information
Date Initiated by Firm June 30, 2023
Date Posted August 25, 2023
Recall Status1 Open3, Classified
Recall Number Z-2465-2023
Recall Event ID 92748
510(K)Number K183623  
Product Classification Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
Product LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000.

Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers:
5830-2916 LS TANDEMLIFE KIT DL29
5840-2417 LS TANDEMLIFE KIT - V24, A17
Code Information S/N and UDI: (1)Kit 5830-2916 Pump SN 00876971 UDI: ( 01)00814112020609(11)230411(17)250219(21)00876971 (2)Kit 5840-2417 Pump SN 00876972 UDI: (01)00814112020609(11)230411(17)250219(21)00876972
Recalling Firm/
Manufacturer		 Cardiac Assist, Inc
240 Alpha Dr
Pittsburgh PA 15238-2906
For Additional Information Contact Deanna Wilke
412-963-7770 Ext. 227
Manufacturer Reason
for Recall		 Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
FDA Determined
Cause 2		 Under Investigation by firm
Action LivaNova - TandemLife made Initial contact by phone/email on June 30,2023 to ensure the affected pumps were quarantined and not used. Other details of the recall, including how the customer is to respond, are included in the customer letter issued July 14, 2023 provided via regular mail and/or email. Letter states reason for recall, health risk and action taken. For questions regarding this Medical Device Removal, please contact your TandemLife representative, or TandemLife Customer Quality at LivaNova.FSCA@livanova.com.
Quantity in Commerce 2 units
Distribution US Nationwide distribution in the states of IL, FL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KFM and Original Applicant = CardiacAssist Inc
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