ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 100 units of Transpac IV transducers and SafeSet Reservoir kits due to a potential for leak.
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, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 100 units of CATH LAB KIT #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18, which includes the Transpac Disposable Straight Pressure Transducer (DSPT) and SafeSet Reservoir blood sampling kits. The recall is being conducted because the company identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
The affected products were distributed nationwide. The specific lot codes associated with this recall are 3265486, 3274836, 3281027, and 3288397. The Transpac DSPT is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor, while the SafeSet Reservoir is a blood sampling system used on patients where periodic blood sampling is required.
Healthcare facilities and consumers should check their inventory for these specific lot codes. If the products are found, they should be removed from use and returned to ICU Medical, Inc. according to the company's instructions.
The recalled product
- Product
- CATH LAB KIT #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18 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 currents
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 100
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)
- 3265486 3274836 3281027 3288397
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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