FDA Device recall Z-0158-2015
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardiopleg…
- FDA Device
- Class II
- terminated
- Published 2014-11-12
On 2014-11-12 the FDA classified a Class II recall of Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardiopleg… by Terumo Cardiovascular Systems, citing defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0158-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-03-01 |
| Published | 2014-11-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
Reason
Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
Identifiers
| code_info | Lot Numbers: MN08, MNI5, MM11, MM18, MM25. Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0. |
|---|
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-0158-2015%22
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