CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report

Central Venous Catheters are indicated recalled by ICU Medical

ICU Medical is recalling Central Venous Catheters are indicated for the assessment of hemodynamic status through, distributed in 18 states. The recall was initiated on 2 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT Number/ UDI-4155999/1 0840619 04642 9, 4192320/1 0840619 04642 9

Quantity recalled60

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-1999-2020
FDA event ID: 85361
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 2 Jan 2020
FDA classified: 14 May 2020
Reported: 20 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

2 Jan 2020	Recall initiated by company
14 May 2020	Classified by FDA	+133 days
20 May 2020	Published in enforcement report	+6 days

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

Reason for recall

Inability for the guidewire to pass through the needles included with the catheter kits.

Product as listed by the FDA

Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23

Where it was distributed

US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA OUS - Canada.

Alabama California Florida Georgia Illinois Maine Michigan Minnesota Mississippi North Carolina New Hampshire New Mexico New York Ohio Texas Utah Virginia Washington

Questions about this recall

Why was it recalled?

Inability for the guidewire to pass through the needles included with the catheter kits.

Which lots are affected?

LOT Number/ UDI-4155999/1 0840619 04642 9, 4192320/1 0840619 04642 9

Where was it sold?

US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA OUS - Canada.

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 26 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

6 other products · FDA event 85361

This product is part of a recall event; the main page for the event is Central Venous Catheters are indicated recalled by ICU Medical.

Reported	Class	Recall	Company	Reason	Where
20 May 2020	CLASS II	Central Venous Catheters are indicated recalled by ICU Medical	ICU Medical	Other	18 states
20 May 2020	CLASS II	Central Venous Catheters are indicated recalled by ICU Medical	ICU Medical	Other	18 states
20 May 2020	CLASS II	Central Venous Catheters are indicated recalled by ICU Medical	ICU Medical	Other	18 states
20 May 2020	CLASS II	Central Venous Catheters are indicated recalled by ICU Medical	ICU Medical	Other	18 states
20 May 2020	CLASS II	Central Venous Catheters are indicated recalled by ICU Medical	ICU Medical	Other	18 states
20 May 2020	CLASS II	Central Venous Catheters are indicated recalled by ICU Medical	ICU Medical	Other	18 states

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Reported	Class	Recall	Company	Reason	Where
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17 Jun 2026Device	CLASS II	Plum Duo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide

Other Heart & Vascular Devices recalls

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Reported	Class	Recall	Company	Reason	Where
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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