FDA Device recall Z-0157-2015
Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line t…
- FDA Device
- Class II
- terminated
- Published 2014-11-12
On 2014-11-12 the FDA classified a Class II recall of Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line t… 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-0157-2015 |
| 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 Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity
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: ML13, MM04. Manufacturing datese September 13, 2010 through October 4, 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-0157-2015%22
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