CLASS II Device recall · Reported 8 Aug 2012 · FDA Enforcement Report

High Pressure Stopcock (3-Way, Luer Lock, Off) recalled by ICU Medical

ICU Medical is recalling High Pressure Stopcock (3-Way, Luer Lock, Off), distributed nationwide in the US. The recall was initiated on 17 Apr 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number 423530401 510(k) K052865 Lot#s: 2432974, 2441508, 2448504, 2455568

Quantity recalled4625

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-2128-2012
FDA event ID: 62538
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 17 Apr 2012
FDA classified: 2 Aug 2012
Reported: 8 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

17 Apr 2012	Recall initiated by company
2 Aug 2012	Classified by FDA	+107 days
8 Aug 2012	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

The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.

Where it was distributed

Nationwide distribution

Nationwide

Questions about this recall

Why was it recalled?

The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.

Which lots are affected?

Part Number 423530401 510(k) K052865 Lot#s: 2432974, 2441508, 2448504, 2455568

Where was it sold?

Nationwide distribution

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

3 other products · FDA event 62538

This product is part of a recall event; the main page for the event is Flush Kit w 3 Way Off Stopcock recalled by ICU Medical.

Reported	Class	Recall	Company	Reason	Where
8 Aug 2012	CLASS II	Flush Kit w 3 Way Off Stopcock recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
8 Aug 2012	CLASS II	94" 20 Drop Admin Set w/High Pressure 4-Way recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
8 Aug 2012	CLASS II	Cardiac Catheterization Waste Management System w/ Waste recalled	ICU Medical	Device Malfunction	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
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
17 Jun 2026Device	CLASS II	Plum Solo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Infusion Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide

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16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide