FDA Device recall Z-1828-2015
Custom Cardiovascular Procedure Kits
- FDA Device
- Class II
- terminated
- Published 2015-07-01
On 2015-07-01 the FDA classified a Class II recall of Custom Cardiovascular Procedure Kits by Terumo Cardiovascular Systems, citing the Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. T….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1828-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-06 |
| Published | 2015-07-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | FL, MO |
Product
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Reason
The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
Identifiers
| code_info | Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1828-2015%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.