SHIP KIT — Class III medical device recall Z-0311-2022
Ongoing recall by Cardiac Assist, Inc, reported 2021-12-08, distributed in DC, MA, SC, VA. Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (corr
| Recall number | Z-0311-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiac Assist, Inc, Pittsburgh, PA, United States |
| Recall initiated | 2021-10-14 |
| Classified | 2021-11-29 |
| Reported by FDA | 2021-12-08 |
| Distributed | DC, MA, SC, VA |
| Quantity | 7 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00814112020791 |
| Serial numbers | 872170, 872171, 872172, 872173, 872182, 872183, 872184 |
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 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)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0311-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.