Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET — Class III medical device recall Z-2104-2018
Terminated recall by Datascope Corporation, reported 2018-06-13, distributed in AL, OR, TX. There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the
| Recall number | Z-2104-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corporation, Fairfield, NJ, United States |
| Recall initiated | 2016-03-11 |
| Classified | 2018-06-06 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2019-06-07 |
| Distributed | AL, OR, TX |
| Quantity | 19 kits |
| UPC / GTIN / UDI-DI | 10607567203300 |
| Lot numbers | 3000020069, 3000021675 |
| Model numbers | 701054588 |
Product
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
Reason for recall
There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
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-2104-2018. 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.