ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk
ICU Medical is recalling 760 Transpac IV Trifurcated Monitoring Kits because of a potential for leaks 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 for leaks, which poses a risk of harm, 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 760 units of the Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, Item No. 42650-06. The affected products were distributed nationwide in the United States.
The recall was initiated because the company identified a potential for leaks with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The source text does not specify whether any injuries or illnesses have been reported.
Healthcare facilities and consumers should stop using the affected kits and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macrodrip (Pole Mount), Item No. 42650-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 760
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)
- 3279183 3226553
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 →Related recalls
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Similar recalls
- HighICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
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