ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 520 Transpac IV Monitoring Kits because of 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 involves a medical device with a potential leak hazard where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 520 units of Transpac IV Monitoring Kits with Arterial 84" SafeSet Reservoir, 03 ml Squeeze Flush Device, and Needleless Valves (Item No. 46112-13). The recall affects lots 3203497 and 3235654, which were distributed nationwide.
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 Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor, while the SafeSet Reservoir system is used for periodic blood sampling on patients.
Healthcare facilities and consumers should stop using the affected products and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- Transpac¿ IV Monitoring Kit w/Arterial 84" Safeset" Reservoir, 03 ml Squeeze Flush Device and Needleless Valves, Item No. 46112-13 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 520
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)
- 3203497 3235654
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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