Z-0361-2016 Class II Terminated
FDA device recall Z-0361-2016 was initiated by Quest Medical, Inc. on October 28, 2015 and is designated Class II. Reason for recall: The products have been found to intermittently exhibit a seal failure during use. The recall status is terminated (terminated November 17, 2016). Affected quantity: 18,761 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2015
- Initiation Date
- October 28, 2015
- Termination Date
- November 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,761 units
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.
Reason for Recall
The products have been found to intermittently exhibit a seal failure during use.
Distribution Pattern
Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.
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