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Maquet Cardiovascular Us Sales, Llc recalls MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia
Recalled March 19, 2014 · FDA recall Z-1165-2014 · Maquet Cardiovascular Us Sales
Hazard
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. · FDA Class II
Units
1,424 units
Sold at
Worldwide Distribution - USA (nationwide) and the countries of Brazil, Germany and Turkey
Description
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.
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.
Manufacturer(s)
Maquet Cardiovascular Us Sales, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →