ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk
ICU Medical is recalling 130 units of Transpac IV transducers and SafeSet Reservoir kits due to a potential leak.
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, which poses a risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 130 units of the Transpac Disposable Straight Pressure Transducer (DSPT) and associated SafeSet Reservoir blood sampling kits. The recall is being conducted because the company identified a potential for leak with these specific devices.
The affected products are the Transpac IV transducers, which interface between a catheter and a pressure monitor, and the SafeSet Reservoir system used for periodic blood sampling. The recall number is Z-0468-2017.
The source text does not specify the distribution scope, specific lot numbers, or dates of distribution. Consumers and healthcare providers should contact ICU Medical, Inc. for further instructions on how to handle the recalled devices.
The recalled product
- Product
- TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064-54 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.
- Hazard
- Affected units
- 130
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)
- 3259345
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 162 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.
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Similar recalls
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