FDA-Device2014-03-19Class II
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.
Maquet Cardiovascular Us Sales, Llc
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.
Sold states
Worldwide Distribution - USA (nationwide) and the countries of Brazil, Germany and Turkey
Affected count
1,424 units
Manufactured in
45 Barbour Pond Drive, N/A, Wayne, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1165-2014Don't want to check this manually?
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