Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR… — Class II medical device recall Z-0157-2015
Terminated recall by Terumo Cardiovascular Systems Corp, reported 2014-11-12, distributed nationwide. Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised
| Recall number | Z-0157-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corp, Ashland, MA, United States |
| Recall initiated | 2011-03-01 |
| Classified | 2014-10-31 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2014-11-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, HK, KR, TH |
| Quantity | 165 units |
| Reason classes | packaging |
| Lot numbers | ML13, MM04 |
| Model numbers | 16110 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0157-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.