ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 1,480 Transpac IV transducers with SafeSet Reservoirs due to a potential leak. The products were distributed nationwide.
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, which poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 1,480 units of the Transpac IV Disposable Transducer with Stopcocks and Without Covers (Item No. 42664-01NS). The recall involves specific SafeSet Reservoir and blood sampling kits that contain these transducers.
The recall was initiated because the company identified a potential for leak with these specific kits. 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. The source text does not specify the exact dates of distribution or the specific states involved. No illnesses or injuries are reported in the source text.
Consumers and healthcare facilities should stop using the affected products and contact ICU Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS AND WITHOUT COVERS, Item No. 42664-01NS 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
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 1,480
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)
- 3280995
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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