FDA Device recall Z-2178-2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Byp…
- FDA Device
- Class II
- terminated
- Published 2018-06-20
On 2018-06-20 the FDA classified a Class II recall of Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Byp… by Datascope, citing there is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2178-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-27 |
| Published | 2018-06-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Datascope |
| Distribution | FL, IA |
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
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Identifiers
| code_info | UDI 0607567204133 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2178-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.