FDA-Device2015-12-09Class II
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.
Quest Medical, Inc.
Hazard
The products have been found to intermittently exhibit a seal failure during use.
Sold states
Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.
Affected count
18,761 units
Manufactured in
1 Allentown Pkwy, Allen, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0361-2016Don't want to check this manually?
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