| | Class 3 Device Recall Cardiac Assist |  |
| Date Initiated by Firm | October 14, 2021 |
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| Create Date | November 29, 2021 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0311-2022 |
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| Recall Event ID |
88972 |
| 510(K)Number | K160257 |
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| Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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| Product | SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass.
Including the following components:
a) 31 Fr ProtekDuo Veno-Venous Cannula Set
b) LifeSPARC Pump
c) 14Fr to 26 Fr Dilator Set
d) TandemHeart Wrap.
Kit Number: 5820-3118
Intended use is applicable to the intended use of specific devices included in the kit. |
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| Code Information |
Serial Numbers:
872170,
872171,
872172,
872173,
872182,
872183,
872184.
UDI:
01)00814112020791(17)220
501(22)220511(21) 872170;
(01)00814112020791(17)220
501(22)220511(21) 872171;
(01)00814112020791(17)220
501(22)220511(21) 872172;
(01)00814112020791(17)220
501(22)220511(21) 872173;
(01)00814112020791(17)220
501(22)220511(21) 872182;
(01)00814112020791(17)220
501(22)220511(21) 872183;
01)00814112020791(17)220
501(22)220511(21) 872184
|
Recalling Firm/
Manufacturer |
Cardiac Assist, Inc
240 Alpha Dr
Pittsburgh PA 15238-2906
|
| For Additional Information Contact | Marnie Smith
412-963-7770 Ext. 227 |
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Manufacturer Reason
for Recall | Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date) |
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FDA Determined
Cause 2 | Error in labeling |
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| Action | LiNova issued an "URGENT MEDICAL DEVICE REMOVAL" letter (FA-CP-PIT-2021-003) dated October 13th, 2021 via e-mail on 14 October 2021. Letter states reason for recall, health risk and action to take:
TandemLife recommends using the device as labelled and dispose the outer packaging.
TandemLife kindly requests your execution of the following actions:
1. Using attached Response Form in Attachment 1 of this letter, please:
- If you have already discarded of outer packaging prior to the receipt of this letter, please proceed to step 2
- Check your inventory for the presence of potentially affected kit contained within your
ordered kit as per Table provided in Attachment 1;
- Please dispose of the outer packaging of your impacted product upon notification
of this letter.
- Please use your devices as labelled on the device level labeling.
2. Return the attached Response Form in Attachment 1 by email to
LivaNova.FSCA@livanova.com to 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.
For questions regarding this Medical Device Removal, please contact your TandemLife
representative, or TandemLife Customer Quality at LivaNova.FSCA@livanova.com.
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| Quantity in Commerce | 7 units |
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| Distribution | US Distribution to states of: DC, MA, SC, and VA. |
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| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = DWF
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