CLASS II Device recall · Reported 13 Aug 2014 · FDA Enforcement Report

Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir recalled

ICU Medical is recalling Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir Squeeze Flush and 6 Needleless, distributed nationwide in the US. The recall was initiated on 18 Jul 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. 2848741, 2859329, 2862831, 2869453

Quantity recalled60 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-2160-2014
FDA event ID: 68971
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 18 Jul 2014
FDA classified: 7 Aug 2014
Reported: 13 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Patient Monitors

Timeline

18 Jul 2014	Recall initiated by company
7 Aug 2014	Classified by FDA	+20 days
13 Aug 2014	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 has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

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

Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

Where it was distributed

Worldwide Distribution - USA including Oregon and Internationally to Australia.

Nationwide Oregon

Questions about this recall

Why was it recalled?

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Which lots are affected?

Lot No. 2848741, 2859329, 2862831, 2869453

Where was it sold?

Worldwide Distribution - USA including Oregon and Internationally to Australia.

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

8 other products · FDA event 68971

This product is part of a recall event; the main page for the event is Transpac IV Trifurcated Monitoring Kit w/84" Safeset recalled.

Reported	Class	Recall	Company	Reason	Where
13 Aug 2014	CLASS II	Transpac IV Trifurcated Monitoring Kit w/84" Safeset recalled	ICU Medical	Packaging Defects	Nationwide
13 Aug 2014	CLASS II	Trifurcated Transpac IT Monitoring Kit w/ Flush Devices recalled	ICU Medical	Packaging Defects	Nationwide
13 Aug 2014	CLASS II	Single Line Transpac IV Monitoring Kit w/ Squeeze Flush recalled	ICU Medical	Packaging Defects	Nationwide
13 Aug 2014	CLASS II	Arterial Transpac IT Monitoring Kit w/Safeset Reservoir recalled	ICU Medical	Packaging Defects	Nationwide
13 Aug 2014	CLASS II	Single Transpac IT Monitoring Kit w/ Flush Device recalled	ICU Medical	Packaging Defects	Nationwide
13 Aug 2014	CLASS II	Arterial Safeset Transpac IT w/ Reservoir and Single CSP recalled	ICU Medical	Packaging Defects	Nationwide
13 Aug 2014	CLASS II	Transpac IT w//HR Macrodrip, Arterial Pressure Tubing and CSP recalled	ICU Medical	Packaging Defects	Nationwide
13 Aug 2014	CLASS II	Transpac IT w/10 cc Safeset Reservoir Flush Device recalled	ICU Medical	Packaging Defects	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	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 Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide