Retiro De Equipo (Recall) de Device Recall MAQUET

Recall

67515

Class 2

Z-1165-2014

2014-01-31

2014-03-10

Terminated

United States

2015-04-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125652

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.

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.