ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 430 units of Transpac IV transducer kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
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 where no injuries or illnesses have been reported, fitting the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 430 units of the Transpac Disposable Straight Pressure Transducer (DSPT) kits, specifically Item No. 46097-66. These kits include a single disposable transducer with a 0.3ml flush device and are designed to interface between a catheter and a pressure monitor. The recall affects kits distributed nationwide, including those shipped to Lutheran General Hospital.
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 SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line, used on patients where periodic blood sampling is required.
Healthcare facilities and consumers who have these specific transducer kits should stop using them immediately. Affected units can be identified by the codes 3226756 and 3261667. Users should contact ICU Medical for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- SINGLE (1) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-66 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting change
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 430
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)
- 3226756 3261667
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