FDA Device recall Z-1165-2014
MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and main…
- FDA Device
- Class II
- terminated
- Published 2014-03-19
On 2014-03-19 the FDA classified a Class II recall of MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and main… by Maquet Cardiovascular Us Sales, citing the MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia Heat Exchanger….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1165-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-31 |
| Published | 2014-03-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | US |
Product
MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.
Reason
The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia Heat Exchanger (PLEGIOX) is used in conjunction with a heater/cooler unit.
Identifiers
| code_info | Order Number Model Number and Description Lot number 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 15674-05 70105.0647…Order Number Model Number and Description Lot number 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 15674-05 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 15929-05 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 16115-06 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 16346-06 70105.0967 BO-T 1260 Adult Cardioplegia Pack 15760-07 70105.0975 BO-TOP 26300 Custom Pack 15796-13 70105.1736 BEQ-TOP 4903 Open Heart Pack 15921-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16073-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16153-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16321-07 70105.1861 BO-TOP 14601 Open Heart Tubing Pack 15880-02 70105.2463 BO-T 25102 Custom Pack 15755-07 70105.2463 BO-T 25102 Custom Pack 15889-07 70105.2463 BO-T 25102 Custom Pack 16046-07 70105.2463 BO-T 25102 Custom Pack 16155-07 70105.2463 BO-T 25102 Custom Pack 16267-07 70105.2650 BO-TOP 23102 Scott &White OR CPB Pack 15818-10 70105.2659 BO-TOP 4903 Adult Open Heart Pack 15780-03 70105.2659 BO-TOP 4903 Adult Open |
|---|
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-1165-2014%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.