Agency classClass IIOur severity:High FDA (Devices)·Z-2814-2016·Announced 2016-09-21

ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential

ICU Medical is recalling 20 units of Single Monitoring Kits with 30mL Flush Devices due to a potential for leak 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 leak hazard where no injuries or illnesses have been reported, fitting the rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling 20 units of Single Monitoring Kits with 30mL Flush Devices, Item No. 46073-38. These kits contain the Transpac IV transducers and are used as extravascular pressure transducers that interface between a catheter and a pressure monitor. The SafeSet Reservoir system included in these kits is a blood sampling system assembled directly to the patient monitoring line for patients requiring periodic blood sampling.

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 affected units were distributed nationwide in the United States. The specific codes associated with the recalled units are 3264706 and 3253229.

Healthcare providers and consumers should check their inventory for the specific item number and codes 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: Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product 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…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Pressure Transducer
Hazard: leak
Affected units: 20

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)

3264706 3253229

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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Same hazard · leak