ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 10 units of Transpac IV Trifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
What this means for you
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 is classified as FDA Class II for a medical device with a potential leak hazard. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).
Plain-English summary
ICU Medical, Inc. is recalling 10 units of Transpac IV Trifurcated Monitoring Kits, Item No. 46113-90. These kits include the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir system, which is used for periodic blood sampling on patients connected to the monitoring line.
The recall was initiated because the company identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The FDA has classified this recall as Class II, indicating a situation that could temporarily cause serious adverse health consequences or where the probability of serious adverse health consequences is remote.
The affected units were distributed nationwide. Healthcare facilities and consumers who have these specific monitoring kits should stop using them and contact ICU Medical, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Transpac¿ IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and Yellow Stripe Tubing, Item No. 46113-90 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure mon
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 10
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)
- 3235658
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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