ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 260 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential for leaks.
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 leaks, which poses a risk of harm to patients, 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 260 units of Transpac IV Monitoring Kits with SafeSet Reservoir and Blood Sampling Port, Item No. 46114-24. These kits include a 0.3 ml Squeeze Flush Device and are distributed nationwide.
The recall was initiated because the company identified a potential for leaks with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor, while the SafeSet Reservoir system is used for periodic blood sampling on patients.
Consumers and healthcare facilities should stop using the affected kits and contact ICU Medical for further instructions.
The recalled product
- Product
- Transpac¿ IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze Flush Device, Macrodrip (Patient Mount), Item No. 46114-24 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a cathe
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 260
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)
- 3261682
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.
See all 162 products in this recall →Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication
FDA (Devices) · 2026-07-22
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
Same hazard · leak
See all →- HighAVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
FDA (Devices) · 2026-08-26
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighAnti-siphon smallbore extension sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05