CLASS II Device recall · Reported 23 Nov 2016 · FDA Enforcement Report

Transpac¿ Iv Bifurcated Kit With Safeset" Reservoir recalled

ICU Medical is recalling Transpac¿ Iv Bifurcated Kit With Safeset" Reservoir And Blood Sampling Ports, 84" Tubing, distributed nationwide in the US. The recall was initiated on 27 Sep 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes3226086
Quantity recalled340 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-0420-2017
FDA event ID
75491
Recalling firm
ICU Medical, San Clemente, CA
Classification
Class II
Status
Terminated
Recall initiated
27 Sep 2016
FDA classified
15 Nov 2016
Reported
23 Nov 2016
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Packaging Defects

Timeline

27 Sep 2016Recall initiated by company
15 Nov 2016Classified by FDA+49 days
23 Nov 2016Published in enforcement report+8 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 Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

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

TRANSPAC¿ IV BIFURCATED KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORTS, 84" TUBING, 2 SQUEEZE FLUSHES, 2 DISPOSABLE TRANSDUCER, MACRODRIP (POLE MOUNT), Item No. 42500-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Which lots are affected?

3226086

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

100 other products · FDA event 75491

This product is part of a recall event; the main page for the event is CATH LAB KIT recalled by ICU Medical.

ReportedClassRecallCompanyReasonWhere
CLASS IICATH LAB KIT recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Bifurcated Monitoring Kit w/ Squeeze Flush recalledICU MedicalPackaging DefectsNationwide
CLASS IITrifurcated Mk W/ Flush Device For Univ recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITrifurcated Disp recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit With Safeset" Reservoir recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit Neonatal, 24" recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIMonitoring Kit W/ Flush Device For Pitt Co. Mem recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIMonitoring Kit With Flush Device For Christ Hospital recalledICU MedicalPackaging DefectsNationwide
CLASS IIKit For University Of Mich recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit, 60" recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIMonitoring Kit W/ Flush Device For Egleston Hosp recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IISingle A Line Kit Cc5 W/ Flush Device For Albert Einstein M.c recalledICU MedicalPackaging DefectsNationwide
CLASS IITriple Disposable Transducer Kit With Flush Device For Lutheran Gen recalledICU MedicalPackaging DefectsNationwide
CLASS IIArt Line Kit W/ Flush Device For Jackson Mem recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit w/3 Port "ON" Manifold (600 psi) recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit, 9" recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIBifurcated Kit W/ Flush Device For Duke University recalledICU MedicalPackaging DefectsNationwide
CLASS IITransducer Kit For Medical Ctr recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIMonitoring Kit #3 w/ Flush Device for Childrens Hosp recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit , 60" recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIPerfusion Kit For Univ recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit w/4 Port "ON" Manifold, Waste, Syringe recalledICU MedicalPackaging DefectsNationwide
CLASS IIQuad Kit With Three Transpac¿ And Flush Devices For St. recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit, 60" recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIArterial Set-up W/ Flush Device For Orlando Reg recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIOpen Heart Kit W/ Flush Device For Cumberland County Hosp recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Monitoring Kit, 60" recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit w/ Intraflo, 2 Port Manifold Right OFF Rotator and TP4 recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Monitoring Kit w/Safeset 72" Pressure Tubing recalledICU MedicalPackaging DefectsNationwide
CLASS IIMonitoring Kit With Flush Device For Lehigh Valley Hospital Center recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit Disposable Transducer Squeeze recalledICU MedicalPackaging DefectsNationwide
CLASS IIDouble Line Safeset" Kit With Flush Device For E.U.S.H.C recalledICU MedicalPackaging DefectsNationwide
CLASS IIQuad Transducer Kit With Flush Device For Lubbock Heart Hosp recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit Disposable Transducer recalledICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit W/ Flush Device for Monongalia General Hosp recalledICU MedicalPackaging DefectsNationwide
CLASS IITrifurcated Transpac¿ IV w/ Squeeze Flush Device recalledICU MedicalPackaging DefectsNationwide
CLASS IIBifurcated Transpac¿ IV Monitoring Kit w/ Squeeze Flush recalledICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit w/3 Port "ON" Manifold Flush Device, Waste recalledICU MedicalPackaging DefectsNationwide
CLASS IIDouble Line Kit W/ Flush Device & Safeset recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIPediatric Arterial Kit W/ Flush Device For Stanford Univ recalledICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit With Flush Device For Memorial Healthcare recalledICU MedicalPackaging DefectsNationwide
CLASS IIMonitoring Kit With Flush Device For Nyu Med Ctr recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit, 72" recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IICardiac Catheterization Right Heart Kit w/2-Station recalledICU MedicalPackaging DefectsNationwide
CLASS II2 Port Right "Off" Manifold w/Admin Set 72" PT recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit For Genesis Health Care recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Trifurcated Monitoring Kit 84" w/ Squeeze recalledICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit W/3 Port "on" Manifold, Waste, Syringe & Tp4 recalledICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit #3 For Mary Hitchcock Hosp recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIRight Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi) recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Trifurcated Monitoring Kit w/ Squeeze Flush recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Trifurcated Monitoring Kit recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIMonitoring Kit w/TP4 Squeeze Flush recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit For Salina Regional recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit w/3 Port ''ON'' Manifold, Waste, TP4 recalledICU MedicalPackaging DefectsNationwide
CLASS IIMonitoring Kit w/TP4 Squeeze Flush and Needleless Valve recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit Safeset" Reservoir And 2 Blood recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Disposable Transducer With Stopcocks recalledICU MedicalPackaging DefectsNationwide
CLASS IICvp Arterial Line Kit With Flush Device For Kansas Heart Hosp recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Disposable Transducer recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Disposable Transducer With 4 Ft recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IISingle Line Safeset" Kit With Flush Device For E.u.s.h.c recalledICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit w/Waste, dyePod¿, Sosa Spike & Syringe recalledICU MedicalPackaging DefectsNationwide
CLASS IITrifurcated Monitoring Kit w/84" Safeset" Reservoir recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Monitoring Kit w/84" Red Stripe TBG recalledICU MedicalPackaging DefectsNationwide
CLASS IICardiac Catheterization Waste Management System Left Heart Kit recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit With 2 Safeset" Blood Sampling recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Monitoring Kit w/ Safeset" Reservoir recalledICU MedicalPackaging DefectsNationwide
CLASS IIPerfusion Pump Kit For Memorial Hosp recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IISingle Disposable Transducer Kit With Flush Device For Lutheran Gen recalledICU MedicalPackaging DefectsNationwide
CLASS IIOpen Heart Kit With Flush Device For Fletcher Allen Health Care recalledICU MedicalPackaging DefectsNationwide
CLASS IIBifurcated Transpac¿ 4 With Flush Device For Buffalo General Hosp recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ 4 kit w/72" Macrodrip¿ Admin Set recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Disposable Transducer With 4 Ft recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Trifurcated Monitoring Kit 72" recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit, Neonatal, 24" recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Bifurcated Monitoring Kit recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIRight Heart Cath Lab Kit For Baptist Mem recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit With Safeset" Reservoir recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Monitoring Kit, 84" recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Trifurcated Monitoring Kit w/84" Safeset" recalledICU MedicalPackaging DefectsNationwide
CLASS IIM.k. With Flush Device For Driscoll Foundation Childrens Hosp recalledICU MedicalPackaging DefectsNationwide
CLASS IITriple Pressure Kit With Flush Device For Methodist M.c recalledICU MedicalPackaging DefectsNationwide
CLASS IIPtca Kit W/ Flush Device For Williamsport Hosp recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit #2 For Mary Hitchcock Mem recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Monitoring Kit w/ Squeeze Flush and Macrodrip recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Bifurcated Monitoring Kit 48" recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit For Baptist M recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIRight Heart Kit For Nc Baptist Hospital recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IICath Lab Kit For Albert Einstein M.c recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITriple Mk W/ Flush Device For Univ Of Penn recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IIMonitoring Kit With Flush Device For Concord Hosp recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Monitoring Kit, 60" Squeeze Flush Device recalledICU MedicalPackaging DefectsNationwide
CLASS IIAdd-on Disp. Transducer W/ Flush Device For Johns Hopkins Hosp recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ IV Monitoring Kit w/ Squeeze Flush Device recalledICU MedicalPackaging DefectsNationwide
CLASS IITriple Kit W/safeset" And Flush Device For O.h.s.u recalledICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Disposable Transducer With 4 Ft recalled by ICU MedicalICU MedicalPackaging DefectsNationwide
CLASS IITranspac¿ Iv Monitoring Kit With Safeset" Reservoir recalledICU MedicalPackaging DefectsNationwide

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