Transpac IV Trifurcated Monitoring Kit w/84" Safeset… recallZ-2157-2014 · ICU Medical, Inc. · initiated Jul 18, 2014
Class II Terminated All recalls posted in August 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ICU Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
ICU Medical, Inc. sent an email dated July 18, 2014, to their customers, The email inform the customer of the problem and the action to be taken. The email stated that the US Sales Representative would remove the recalled product on July 22, 2014. If product was further distribution customers should notify their customers. Customer was informed of the RGA to have the recalled product returned. For questions regarding this recall call 801-264-1732.
Recall details
- Recall number
- Z-2157-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 18, 2014
- Posted by the FDA
- Aug 7, 2014
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 20 units
- Product code
- DRS
- FDA submissions
- K061573
- Distribution
- Worldwide Distribution - USA including Oregon and Internationally to Australia.
Product description
Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 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.
Code information (models, lots, serial numbers)
Lot No. 2886730
Other devices under the same FDA submission
22 devices cleared under K061573 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ICU Medical 46104-07Icu Medical, Inc. · Transducer, blood-pressure, extravascular7 reports
- ICU Medical 42650-06Icu Medical, Inc. · Transducer, blood-pressure, extravascular5 reports
- ICU Medical 42648-06Icu Medical, Inc. · Transducer, blood-pressure, extravascular4 reports
- ICU Medical 42598-01Icu Medical, Inc. · Transducer, blood-pressure, extravascular3 reports
- ICU Medical 46115-65Icu Medical, Inc. · Transducer, blood-pressure, extravascular3 reports
- ICU Medical 42585-05Icu Medical, Inc. · Transducer, blood-pressure, extravascular2 reports
- ICU Medical 42632-05Icu Medical, Inc. · Transducer, blood-pressure, extravascular2 reports
- ICU Medical 42590-05Icu Medical, Inc. · Transducer, blood-pressure, extravascular2 reports
- ICU Medical 852-011-46104-58Icu Medical, Inc. · Transducer, blood-pressure, extravascular2 reports
- ICU Medical 42408-11Icu Medical, Inc. · Transducer, blood-pressure, extravascular1 report
- ICU Medical 42586-05Icu Medical, Inc. · Transducer, blood-pressure, extravascular1 report
- ICU Medical 42582-05Icu Medical, Inc. · Transducer, blood-pressure, extravascular1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 68971).
- Z-2158-2014 · TerminatedTrifurcated 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, squ…
- Z-2159-2014 · TerminatedArterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoi…
- Z-2160-2014 · TerminatedTrifurcated 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 Res…
- Z-2161-2014 · TerminatedSingle Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flus…
- Z-2162-2014 · TerminatedArterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze fl…
- Z-2163-2014 · TerminatedTranspac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling por…
- Z-2164-2014 · TerminatedSingle Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, …
- Z-2165-2014 · TerminatedTranspac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze f…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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