Model 5001102 MPS Delivery Set w/ arrest agent and additive… recallZ-0361-2016 · Quest Medical, Inc. · initiated Oct 28, 2015
Class II Terminated All recalls posted in December 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Quest Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The products have been found to intermittently exhibit a seal failure during use.
FDA root cause category: Equipment maintenance
What the company is doing
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.
Recall details
- Recall number
- Z-0361-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 28, 2015
- Posted by the FDA
- Dec 2, 2015
- Recalling firm
- Quest Medical, Inc.
- Quantity
- 18,761 units
- Product code
- DTR
- FDA submissions
- K953838
- Distribution
- Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
4 devices cleared under K953838 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MPS 5001102Quest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass42 reports
- MPS 5001102-ASQuest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass7 reports
- MPS Console 5001000Quest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass4 reports
- Delivery Set 16C w/ AA 35cm Line 5161102Quest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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