Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB — Class II medical device recall Z-2178-2018
Terminated recall by Datascope Corporation, reported 2018-06-20, distributed in FL, IA. There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
| Recall number | Z-2178-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corporation, Fairfield, NJ, United States |
| Recall initiated | 2017-07-27 |
| Classified | 2018-06-13 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2020-02-07 |
| Distributed | FL, IA |
| Quantity | 10 |
| UPC / GTIN / UDI-DI | 00607567204133 |
| Model numbers | 701056035 |
Product
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
Reason for recall
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
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-2178-2018. 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.