Agency classClass IIOur severity:High FDA (Devices)·Z-2824-2016·Announced 2016-09-21

ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

ICU Medical is recalling 100 units of Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak hazard.

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, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling 100 units of Transpac IV Monitoring Kits with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve (Item No. 46104-53). The recall is due to a potential for leak identified in certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

The affected products were distributed nationwide in the United States. The specific lot codes associated with this recall are 3281531 and 3226847. The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor, while the SafeSet Reservoir system is used for periodic blood sampling on patients.

Consumers and healthcare providers should check their inventory for the specific item number and lot codes listed above. If the product matches the recalled description, it should be removed from use and returned to the manufacturer or a designated distributor for replacement or refund.

The recalled product

Product: Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Monitoring / Blood Sampling
Hazard: leak
Affected units: 100

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)

3281531 3226847

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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