Home / Recalls / Quest Medical, Inc. / Z-0361-2016

Z-0361-2016 Class II Terminated

Recalled by Quest Medical, Inc. — Allen, TX

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

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  • Z-2107-2020 Class II — Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (December 17, 2019)
  • Z-1368-2015 Class II — LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmol (February 26, 2015)