Quest Medical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0361-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.

Product Classification:

Class II

Date Initiated: October 28, 2015

Date Posted: December 9, 2015

Recall Number: Z-0361-2016

Event ID: 72524

Reason for Recall:

The products have been found to intermittently exhibit a seal failure during use.

Status: Terminated

Product Quantity: 18,761 units

Code Information:

0491795E04, 0492175E04, 0492185E06, 0492195E06, 0492615E06, 0492625E08, 0492635E08, 0489905Y04, 0490245Y06, 0493075U02, 0493085U02, 0493435U04, 0493675U04, 0493685U07, 494465U07, 0494475U09, 0494855G01, 0495215U11, 0495225U11, 0495505G02, 495515G02, 0496535G08, 0496875G08, 496885G08, 0497245S02, 0495205U11, 497255S04, 0497655S04, 0498535S06, 0498545S06, 0492205E03, 0493695U04, 0494485U07, 0495525G02, 0497265S02, 0495965G04, 0492765E07

Distribution Pattern:

Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.

Voluntary or Mandated:

Voluntary: Firm initiated