Agency classClass IIOur severity:High FDA (Devices)·Z-2808-2016·Announced 2016-09-21

ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential for leaks in the SafeSet Reservoir and blood sampling components.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential for leaks, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of Transpac IV Monitoring Kits with 2 SafeSet Blood Sampling Ports. The affected products include Item No. 42619-08, which features 60-inch tubing, a disposable transducer, and a 3 mL Intraflo Flush. The recall involves 60 units distributed nationwide in the United States.

The recall was initiated because ICU Medical identified a potential for leaks with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The Transpac Disposable Straight Pressure Transducer is an extravascular pressure transducer used to interface between a catheter and a pressure monitor, while the SafeSet Reservoir system is used for periodic blood sampling on patients.

Healthcare facilities and consumers should check their inventory for the specific lot numbers 3280976 and 3256901. If these items are found, they should be removed from use and returned to the supplier or the manufacturer in accordance with standard recall procedures.

The recalled product

Product: 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…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Monitoring / Blood Sampling
Hazard: leak
Affected units: 60

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

lot number 3280976
3256901

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 24 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 24 products in this recall →

Same manufacturer · ICU Medical, Inc.

See all →

High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23

Same hazard · leak