FDA Device recall Z-2105-2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
- FDA Device
- Class III
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class III recall of Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490 by Datascope, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2105-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-03-11 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Datascope |
| Distribution | AL, OR, TX |
Product
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
Reason
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.
Identifiers
| code_info | Batch Number 3000020957, UDI Code 10607567203522 |
|---|
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-2105-2018%22
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