CLASS II Device recall · Reported 13 May 2015 · FDA Enforcement Report

98" Transfer Set w/MicroClave T-Connector, Check Valve recalled

ICU Medical is recalling 98" Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext, distributed nationwide in the US. The recall was initiated on 20 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. 2997914 2997918 2998570 3001230 3001231

Quantity recalled900 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-1594-2015
FDA event ID: 71028
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 20 Apr 2015
FDA classified: 7 May 2015
Reported: 13 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Infusion Pumps

Timeline

20 Apr 2015	Recall initiated by company
7 May 2015	Classified by FDA	+17 days
13 May 2015	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

ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Where it was distributed

Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN

Nationwide Connecticut Florida Kentucky Maryland Minnesota North Carolina South Carolina Tennessee Virginia

Questions about this recall

Is 98" Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext recalled?

Yes. ICU Medical recalled 98" Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext on 20 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1594-2015.

Why was it recalled?

ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

Which lots are affected?

Lot No. 2997914 2997918 2998570 3001230 3001231

Where was it sold?

Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN

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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