Z-0361-2016Class II

Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery...

Name: Z-0361-2016 Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery...
Creator: Quest Medical, Inc.
Published: 2015-10-28
License: https://open.fda.gov/license/

Quest Medical, Inc / initiated 2015-10-28 / Terminated / root cause: manufacturing process

FDA source

Quest Medical, Inc. began a recall of 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... on 2015-10-28. FDA classified it as Class II and gives the reason as "The products have been found to intermittently exhibit a seal failure during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0361-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-28
Posted: 2015-12-02
Terminated: 2016-11-17
Recalling firm: Quest Medical, Inc
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.
Product code: DTR Heat-Exchanger, Cardiopulmonary Bypass
Reason for recall: The products have been found to intermittently exhibit a seal failure during use.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The recalling firm issued a press release on 10/28/2015. The press release was posted on FDA website on 10/29/2015. The recalling firm emailed affected consignees on 10/28/15 and sent out recall letters via USPS beginning 10/30/15.
Quantity in commerce: 18,761 units
Distribution: Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0361-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0361-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-12-02

Product code DTR

K953838Class IIMyocardial Protection SystemQuest Medical, Inc. / cleared 1996-03-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)