Date Initiated by Firm | March 06, 2020 |
Create Date | May 11, 2020 |
Recall Status1 |
Terminated 3 on November 20, 2020 |
Recall Number | Z-1950-2020 |
Recall Event ID |
85322 |
510(K)Number | K110493 |
Product Classification |
Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
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Product | TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system. |
Code Information |
Serial Numbers: S/N 00142612 00142614 00142657 00142658 00142659 00142660 00142661 00142663 00142937 00142938 00142941 00142942 00142970 00142971 00142972 |
Recalling Firm/ Manufacturer |
Cardiac Assist, Inc 240 Alpha Dr Pittsburgh PA 15238-2906
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For Additional Information Contact | SAME 412-963-7770 Ext. 227 |
Manufacturer Reason for Recall | Failure to prime due to an assembly error |
FDA Determined Cause 2 | Under Investigation by firm |
Action | LivaNova dba Tandem Life notified consignees via 1st class mail (certified return receipt) on March 06th, 2020, states reason for recall, health risk, and action to take:
Check your inventory for the presence of potentially affected TandemHeart pump contained within your ordered kit as per Table 1 provided in Attachment 1;
- Ensure any affected kit containing the potentially affected TandemHeart pump still in inventory gets quarantined before they can be returned.
2. Please fill and return Response Form by email to LivaNova.FSCA@livanova.comto confirm appropriate corrective actions have been executed. Please return the Response Form even if each potentially affected device listed in Attachment 1 has already been used.
3. Potentially affected product still in your inventory will be replaced once the Response Form has been returned to LivaNova. Leverage your TandemLife representativeto aid in the collection of the affected quarantined kit containing the potentially affected TandemHeart pump.
Questions regarding this Medical Device Removal, please contact your TandemLife representative, or TandemLife Customer Quality at LivaNova.FSCA@livanova.com. |
Quantity in Commerce | 15 |
Distribution | US Nationwide distributions. |
Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KFM
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