Quest Medical, Inc. recalls Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 500

Recalled December 9, 2015 · FDA recall Z-0361-2016 · Quest Medical

Hazard

The products have been found to intermittently exhibit a seal failure during use. · FDA Class II

Units

18,761 units

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Quest Medical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →