CLASS II Device recall · Reported 9 Dec 2015 · FDA Enforcement Report

Model 5001102 MPS Delivery Set w/ arrest agent and additive recalled

Quest Medical is recalling Model 5001102 MPS Delivery Set w/ arrest agent and additive, distributed nationwide in the US. The recall was initiated on 28 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes0491795E04, 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

Quantity recalled18,761 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0361-2016
FDA event ID: 72524
Recalling firm: Quest Medical, Allen, TX
Classification: Class II
Status: Terminated
Recall initiated: 28 Oct 2015
FDA classified: 2 Dec 2015
Reported: 9 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

28 Oct 2015	Recall initiated by company
2 Dec 2015	Classified by FDA	+35 days
9 Dec 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The products have been found to intermittently exhibit a seal failure during use.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.

Nationwide

Questions about this recall

Is Model 5001102 MPS Delivery Set w/ arrest agent and additive recalled?

Yes. Quest Medical recalled Model 5001102 MPS Delivery Set w/ arrest agent and additive on 28 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0361-2016.

Why was it recalled?

The products have been found to intermittently exhibit a seal failure during use.

Which lots are affected?

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

Where was it sold?

Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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