Friday, 15 January 2016 00:00

Recall Of Myocardial Protection System (Mps) Delivery Sets By Quest Medical, Inc. Due To Intermittent Seal Failure During Use

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The attention of the agency has been drawn to nationwide voluntary recall of lots 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. These products were manufactured from May 2015 to September 2015 and distributed from June 2015 to September 2015.

Loss of blood during surgery can result to anaemia which when severe causes shock leading to damage to organs such as kidney and brain, heart attacks, gangrenes of arms and legs and death of patient undergoing surgery and so Quest Medical Inc. Is asking doctors using the device to cease use of the device affected lot and return them to place of purchase for replacement.

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

Action required from doctors

Doctors should be aware of this 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: This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC….Safeguarding the health of the Nation

Read 11776 times Last modified on Wednesday, 18 May 2016 14:28

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