CLASS II Device recall · Reported 21 Sep 2016 · FDA Enforcement Report

Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling recalled

ICU Medical is recalling Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" Tubing, Disposable, distributed nationwide in the US. The recall was initiated on 10 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslot number 3280976, 3256901

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-2808-2016
FDA event ID: 74966
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 10 Aug 2016
FDA classified: 15 Sep 2016
Reported: 21 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

10 Aug 2016	Recall initiated by company
15 Sep 2016	Classified by FDA	+36 days
21 Sep 2016	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 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 Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole Mount), Item No. 42619-08 Usage: 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

US 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?

lot number 3280976, 3256901

Where was it sold?

US 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

23 other products · FDA event 74966

This product is part of a recall event; the main page for the event is Monitoring Kit with Flush Device recalled by ICU Medical.

Reported	Class	Recall	Company	Reason	Where
21 Sep 2016	CLASS II	Monitoring Kit with Flush Device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Transpac IV Monitoring Kit with SafeSet Arterial Pressure recalled	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Monitoring Kit with TP4 Squeeze Flush and Needleless Valve recalled	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Transpac IV Monitoring Kit with SafeSet Reservoir recalled	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Monitoring Kit with Flush Device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Transpac IV Trifurcated Kit With Safeset Reservoir recalled	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Pediatric Kit with Flush Device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	SafeSet Kit with Flush Device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	5 Port OFF Manifold with Transpac IV recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Monitoring Kit with TP4 Squeeze Flush Device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial recalled	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Transpac IV Bifurcated Kit with SafeSet Reservoir Squeeze recalled	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Transpac IV Monitoring Kit with Squeeze Flush recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Transpac IV Trifurcated Monitoring Kit recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Bifurcated SafeSet Kit with Flush Device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Transpac IV Monitoring Kit with SafeSet 84" Arterial recalled	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Triple Line SafeSet Kit with Flush Device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Transpac IV Trifurcated Monitoring Kit recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Transpac IV Trifurcated Monitoring Kit recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Transpac IV Monitoring Kit with 2 SafeSet Reservoir recalled	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Single Monitoring Kit with Flush Device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve recalled	ICU Medical	Packaging Defects	Nationwide
21 Sep 2016	CLASS II	Double Kit with SafeSet and Flush Device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide

More recalls from ICU Medical

All 654

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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	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide