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

Transducer Kit For Medical Ctr recalled by ICU Medical

ICU Medical is recalling Transducer Kit For Medical Ctr, 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 codes3231400

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-0525-2017
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
Device type: Heart & Vascular Devices

Timeline

27 Sep 2016	Recall initiated by company
15 Nov 2016	Classified by FDA	+49 days
23 Nov 2016	Published 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

TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 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

Is Transducer Kit For Medical Ctr recalled?

Yes. ICU Medical recalled Transducer Kit For Medical Ctr on 27 Sep 2016. The recall is Class II and its status is Terminated. Recall number Z-0525-2017.

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?

3231400

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 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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