Recall: Myocardial Protection System (MPS) Delivery Sets by Quest Medical for Intermittent Seal Failure During Use

Newsroom

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
Device Model 5001102 5001102-AS 7001102
UDI 00634624501126 00634624521124 00634624701120
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: pharmacovigilance@nafdac.gov.ng

 

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About Bob Aroture 540 Articles
Bob is a Senior Editor and Content Development Manager at Nigerian Law Intellectual Property Watch. He holds a BS degree, with a major in biochemistry. He works directly with the Newsroom Team. His focus areas are technology and innovation, and pharmaceutical technology. Email: editorial@nlipw.com