ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk
ICU Medical is recalling 140 units of Transpac Disposable Straight Pressure 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 leak hazard, 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 High severity score (risk-of-harm products where injury has not yet been reported).
Plain-English summary
ICU Medical, Inc. is recalling 140 units of CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37. The recalled items include the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir blood sampling system. These devices are used to interface between a catheter and a pressure monitor and for periodic blood sampling in 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 3265491, 3274839, 3281031, 3288402, and 3303710.
Healthcare facilities and consumers should check their inventory for these specific item numbers and lot codes. If the recalled products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. No specific instructions for consumer action beyond identifying the affected units are provided in the source text.
The recalled product
- Product
- CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37 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 that
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 140
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)
- 3265491 3274839 3281031 3288402 3303710
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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