Agency classClass IIOur severity:High FDA (Devices)·Z-2805-2016·Announced 2016-09-21

ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

ICU Medical is recalling 420 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak. The affected units were distributed nationwide in the US.

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 leak hazard where no injuries or illnesses have been reported, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling 420 units of Transpac IV Monitoring Kits with SafeSet 84-inch Arterial Pressure Tubing, Reservoir, Squeeze Flush, and 2 Needleless Valves (Item No. 011-42646-66). The recall involves specific lot numbers 3273075 and 3265340. These kits were distributed nationwide in the United States.

The recall was initiated because ICU Medical identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and 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 item number and lot numbers listed above. If the product is found, it should be removed from use and returned to ICU Medical, Inc. according to the company's instructions.

The recalled product

Product: Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Monitoring / Pressure Transducer
Hazard: leak
Affected units: 420

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 (1)

Lot numbers 3273075 and 3265340.

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.

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