Recall archive / FDA device enforcement
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components... — FDA record Z-0311-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 14, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- 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)
- Classification
- Class III
- Recalling firm
- Cardiac Assist, Inc
- Quantity
- 7 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0311-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to states of: DC, MA, SC, and VA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 8, 2021
- Recall initiation date
- Oct 14, 2021
- Center classification date
- Nov 29, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.