Terumo Custom Cardioplegia Delivery Set — Class II medical device recall Z-0156-2015
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 s
| Recall number | Z-0156-2015 |
|---|---|
| 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 |
| Reason classes | packaging |
| Lot numbers | MF24, MM11, MN01, MN08, MN29, MNI5, MP07 |
| Model numbers | 16010, 1610, 5852, 58520 |
Product
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the 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-0156-2015. 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.