CLASS II Device recall · Reported 17 Feb 2021 · FDA Enforcement Report

Appx, Pur Yellow Ext, 1.2 Micron Filter recalled by ICU Medical

ICU Medical is recalling Appx, Pur Yellow Ext, 1.2 Micron Filter, distributed nationwide in the US. The recall was initiated on 2 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDistributed O.U.S. only Model List Number: 011-H3182 UDI: (01)1084061905261(17)250401(30)50(10)4806428 Lot Number: 4806428

Quantity recalledTotal Kits = 7,500 for all four lots

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-0958-2021
FDA event ID: 86973
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 2 Dec 2020
FDA classified: 5 Feb 2021
Reported: 17 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

2 Dec 2020	Recall initiated by company
5 Feb 2021	Classified by FDA	+65 days
17 Feb 2021	Published in enforcement report	+12 days

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

Reason for recall

Due to the incorrect filter assembly.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

Where it was distributed

Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium.

Nationwide Arizona California Colorado Connecticut Florida Idaho Illinois Louisiana Massachusetts Minnesota North Carolina New Jersey New York Tennessee Texas Virginia Washington West Virginia

Questions about this recall

Why was it recalled?

Due to the incorrect filter assembly.

Which lots are affected?

Distributed O.U.S. only Model List Number: 011-H3182 UDI: (01)1084061905261(17)250401(30)50(10)4806428 Lot Number: 4806428

Where was it sold?

Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium.

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.

Other products in this recall event

3 other products · FDA event 86973

This product is part of a recall event; the main page for the event is 60" Appx, Smallbore Ext Set w/MicroClave¿ Clear recalled by ICU Medical.

Reported	Class	Recall	Company	Reason	Where
17 Feb 2021	CLASS II	60" Appx, Smallbore Ext Set w/MicroClave¿ Clear recalled by ICU Medical	ICU Medical	Sterility	Nationwide
17 Feb 2021	CLASS II	Appx, Smallbore Set, MicroCLAVE, Filter SetSource recalled	ICU Medical	Sterility	Nationwide
17 Feb 2021	CLASS II	Appx, Pur Yellow Smallbore Set, Filter recalled by ICU Medical	ICU Medical	Sterility	Nationwide

More recalls from ICU Medical

All 654

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	Hotline Fluid Warming Set, single use device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
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17 Jun 2026Device	CLASS II	Plum Solo Precision IV Pump recalled by ICU Medical	ICU Medical	Lead & Heavy Metals	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Infusion Pump recalled by ICU Medical	ICU Medical	Lead & Heavy Metals	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Precision IV Pump recalled by ICU Medical	ICU Medical	Lead & Heavy Metals	Nationwide

Other Heart & Vascular Devices recalls

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Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide