Recall Z-1165-2014
Maquet Cardiovascular Us Sales, Llc · initiated January 31, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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 Heart Pack 16047-03 70105.3832 BO-TOP 32400 Adult CPB Pack 15814-06 70105.3832 BO-TOP 32400 Adult CPB Pack 16063-06 70105.3832 BO-TOP 32400 Adult CPB Pack 16449-06 70105.5015 BO-TOP 36500 Cardiac Surgery 15658-13…
Reason for recall
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-determined cause: Device Design
Action taken
Maquet Inc.sent an" Field Safety Notice" dated January 31, 2014, to all affected customers via Fed Ex. The letter identified the product the problem and the action needed to be taken by the customer. Any questions or additional information, can be obtained from the MAQUET representative, or MAQUET Customer Service at 1-888-627-8383 (press option 2, followed by option 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. Please complete and return the enclosed confirmation form, acknowledging your receipt and understanding of this communication, by emailing a scanned copy to Fieldactions@maquet.com or via fax at (973) 807-9290.
Details
- Recall number
- Z-1165-2014
- Initiated
- January 31, 2014
- Posted by FDA
- March 10, 2014
- Terminated
- April 24, 2015
- Product code
- DTR – Heat-Exchanger, Cardiopulmonary Bypass
- Quantity
- 1,424 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Brazil, Germany and Turkey
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc, Wayne, NJ