The National Agency for Food and Drugs Administration and Control (NAFDAC) is alerting the Public about the nationwide voluntary recall of a number of Myocardial Protection System delivery sets by Quest Medical, Inc. The product(s) have been found to intermittently exhibit a seal failure during use, which potentially could result in patient blood loss. The recalled products were manufactured from May 2015 to September 2015 and distributed from June 2015 to September 2015.
Last October, the U.S. Food and Drug Administration (FDA) issued a similar alert.
The following models/UDI/ID numbers are subject to the recall:
|Device Name||MPS Delivery Set w/arrest agent and additive cassettes, heat exchanger & 10 ft. delivery tubing||MPS Delivery Set with 6 ft. delivery tubing||MPS Low Volume Delivery Set|
|Affected Lots||0491795E04, 0492175E04, 0492185E06, 0492195E06, 0492615E06, 0492625E08 0492635E08, 0489905Y04, 0490245Y06, 0493075U02, 0493085U02, 0493435U04 0493675U04, 0493685U07, 0494465U07, 0494475U09, 0494855G01, 0495215U11 0495225U11, 0495505G02, 0495515G02, 0496535G08, 0496875G08, 0496885G08 0497245S02||0492205E03 0493695U04 0494485U07 0495525G02 0497265S02||0492765E07|
Reporting to NAFDAC
NAFDAC is asking health care professionals to be aware of this recall alert and report blood losses related to the use of these products to NAFDAC PRASCOR system (send text to 20543 from all network providers) or via adverse event report forms or email: firstname.lastname@example.org