ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 140 units of TP4 Kits with SafeSet Reservoirs due to a potential for leaks. The affected medical devices were distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
ICU Medical, Inc. is recalling 140 units of TP4 Kits with 10cc SafeSet Reservoirs, Needleless Valves, Filter Millex, and Admin Sets (Item No. 46104-65). These kits contain Transpac IV transducers, which are extravascular pressure transducers used to interface between a catheter and a pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line for patients requiring periodic blood sampling.
The recall was initiated because ICU Medical identified a potential for leaks with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The affected units are identified by lot number 3275005.
The affected products were distributed nationwide in the United States. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
- 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)
- lot number 3275005
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 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 24 products in this recall →Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · leak
See all →- SevereFresenius Medical Care Recalls 5008X Standard HD Pre-Flush Blood Tubing Sets
FDA (Devices) · 2026-09-09
- 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
Similar recalls
- HighICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
FDA (Devices) · 2016-11-23
- HighICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential
FDA (Devices) · 2016-11-23
- HighICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
FDA (Devices) · 2016-11-23
- HighICU Medical Recalls Transpac IV Transducers Due to Potential Leak
FDA (Devices) · 2016-11-23
- HighICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
FDA (Devices) · 2016-11-23
- HighICU Medical Recalls Transpac IV Kits Due to Potential Leak
FDA (Devices) · 2016-11-23