FDA Device recall Z-0160-2015
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is…
- FDA Device
- Class II
- terminated
- Published 2014-11-12
On 2014-11-12 the FDA classified a Class II recall of Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is… 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-0160-2015 |
| 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 Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: 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: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the 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 | Catalog Number: 165720 Lot Numbers: MDI5, MD15B, MD22, ME19, MP13. Manufacturing dates March 15, 20 I 0 through De…Catalog Number: 165720 Lot Numbers: MDI5, MD15B, MD22, ME19, MP13. Manufacturing dates March 15, 20 I 0 through December 13, 20 I 0. Catalog Number: 6375 Lot Numbers: MD15, ME19, MPI3 Manufacturing dates March 15, 2010 through December 13, 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-0160-2015%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.