ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 210 units of Transpac IV 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 involves a medical device with a potential leak hazard. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
ICU Medical, Inc. is recalling 210 units of Bifurcated Transpac IV Monitoring Kits, Item No. 46107-68. These kits include a 0.3 ml Squeeze Flush Device, Red and Blue Stripe PT Tubing, and a Transpac Disposable Straight Pressure Transducer (DSPT). The DSPT is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor, while the SafeSet Reservoir system is used for periodic blood sampling on patients.
The recall was initiated because ICU Medical identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The affected units were distributed nationwide. The specific lot codes associated with this recall are 3226908 and 3281606.
Healthcare facilities and consumers should check their inventory for the specific item number and lot codes listed above. If the affected units are found, they should be removed from use and returned to ICU Medical, Inc. according to the company's instructions.
The recalled product
- Product
- Bifurcated Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Red and Blue Stripe PT Tubing, Item No. 46107-68 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by co
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 210
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)
- 3226908 3281606
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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