ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 380 units of Transpac IV Disposable Transducers with Stopcocks due to a potential for leak in the SafeSet Reservoir and blood sampling kits.
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 for leak, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 380 units of the Transpac IV Disposable Transducer with Stopcocks, Item No. 42500-03. The product is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor. The recall involves the SafeSet Reservoir system, which is a blood sampling system assembled directly to the patient monitoring line.
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.
Healthcare facilities and consumers should stop using the affected transducers and contact ICU Medical for further instructions. The recall number is Z-0419-2017.
The recalled product
- Product
- TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical curr
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 380
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)
- 3232120
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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