ICU Medical Recalls Pediatric CVL Monitoring Kits Due to Leak Risk
ICU Medical is recalling 40 Pediatric CVL Monitoring Kits containing Transpac IV transducers 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 to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 40 units of the Pediatric CVL Monitoring Kit with 0.3ml Flush Device for Yale New Haven Hospital, Item No. 46094-06. The product includes the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir blood sampling system. These kits 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.
Healthcare facilities and consumers should stop using the affected kits and contact ICU Medical for instructions on return or replacement. No specific lot numbers or dates are provided in the source text.
The recalled product
- Product
- PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., Item No. 46094-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in press
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 40
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)
- 3235554
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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