ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 240 Transpac IV Monitoring Kits because of a potential 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 injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ICU Medical, Inc. is recalling 240 units of Transpac IV Monitoring Kits with SafeSet Reservoir, 24-inch tubing, 3 ml Intraflo Flush and Needleless Valve (Item No. 46103-68). The recall is due to a potential for leak identified in certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor. 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. The affected products were distributed nationwide.
Healthcare providers and consumers should stop using the affected kits and contact ICU Medical for further instructions or a replacement. The recall number is Z-0546-2017.
The recalled product
- Product
- Transpac¿ IV Monitoring Kit w/ Safeset Reservoir, 24" Tubing,03 ml Intraflo¿ Flush and Needleless Valve, Item No. 46103-68 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 240
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)
- 3259421
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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