ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling Transpac IV Monitoring Kits because the SafeSet Reservoir and blood sampling components may 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 for leak, 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 Transpac IV Monitoring Kits, Item No. 42584-05. The recall involves 38,160 units that were distributed nationwide. These kits include a 60-inch disposable transducer, a 3 ml squeeze flush device, and a macrodrip system.
The recall was initiated because ICU Medical identified a potential for leaks in certain SafeSet Reservoir and blood sampling kits that contain the Transpac IV transducers. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line, used on patients where periodic blood sampling is required.
Healthcare facilities and consumers should stop using the affected units. The affected lots are identified by the following codes: 3178532, 3184461, 3202001, 3240576, 3240578, 3240583, 3247915, 3253198, 3253199, 3261706, 3261707, 3261708, and 3265284. Users should contact ICU Medical for instructions on returning or replacing the devices.
The recalled product
- Product
- Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush Device, Macrodrip, Item No. 42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 38,160
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.
See all 162 products in this recall →Related recalls
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Similar recalls
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