CLASS II Device recall · Reported 13 Aug 2014 · FDA Enforcement Report
Trifurcated Transpac IT Monitoring Kit w/ Flush Devices recalled
ICU Medical is recalling Trifurcated Transpac IT Monitoring Kit w/ Flush Devices, Needleless Valve and Macrodrip, 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
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-2158-2014
- 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
- 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 IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 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.
Questions about this recall
Is Trifurcated Transpac IT Monitoring Kit w/ Flush Devices, Needleless Valve and Macrodrip recalled?
Yes. ICU Medical recalled Trifurcated Transpac IT Monitoring Kit w/ Flush Devices, Needleless Valve and Macrodrip on 18 Jul 2014. The recall is Class II and its status is Terminated. Recall number Z-2158-2014.
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. 2873662
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.
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