Quest Medical, Inc. recalls Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 50…

Recall date

October 28, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0361-2016

FDA classification

Class II

Brand / firm

Quest Medical, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.