Reported Dec 8, 2021 · Ongoing
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components:…
Cardiac Assist, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardiac Assist, Inc · 240 Alpha Dr · Pittsburgh, PA · 15238-2906
Is this the product you have?
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 31 Fr ProtekDuo Veno-Venous Cannula Set |
| 2 | LifeSPARC Pump |
| 3 | 14Fr to 26 Fr Dilator Set |
| 4 | TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit. |
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 00814112020791872170, 872171, 872172, 872173, 872182, 872183, 872184. UDI: 01)00814112020791(17)220 501(22)220511(21) 872170 2 00814112020791(01)00814112020791(17)220 501(22)220511(21) 872171 3 00814112020791(01)00814112020791(17)220 501(22)220511(21) 872172 4 00814112020791(01)00814112020791(17)220 501(22)220511(21) 872173 5 00814112020791(01)00814112020791(17)220 501(22)220511(21) 872182 6 00814112020791(01)00814112020791(17)220 501(22)220511(21) 872183 7 0081411202079100814112020791(17)220 501(22)220511(21) 872184 - Amount recalled
- 7 units
Where it was sold
Why it was recalled
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)
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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