ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV Monitoring Kits and SafeSet Reservoirs due to a potential leak. The affected units 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 is classified as FDA Class II. The hazard is a potential leak in a medical device used for blood sampling and pressure monitoring. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
ICU Medical, Inc. is recalling specific lots of Transpac IV Monitoring Kits, Neonatal, 24", with Disposable Transducer, 30 ml Intraflo Flush (Infusion Pump), Item No. 42588-05. The recall involves 1,740 units that were distributed nationwide. The product includes the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir system, which is used for blood sampling on patients requiring periodic sampling.
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 source text does not specify the exact mechanism of the leak or any reported injuries or illnesses associated with the defect.
Healthcare facilities and consumers should stop using the affected product immediately. Users should check their inventory for the specific item number 42588-05 and the following lot codes: 3226274, 3264108, 3265439, 3269745, and 3280964. If the product is found, it should be removed from use and returned to the supplier or the manufacturer for further instructions.
The recalled product
- Product
- TRANSPAC¿ IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO¿ FLUSH (INFUSION PUMP), Item No. 42588-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 1,740
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)
- 3226274 3264108 3265439 3269745 3280964
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 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 Monitoring Kits Due to Leak Risk
FDA (Devices) · 2016-09-21
- HighICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
FDA (Devices) · 2016-09-21
- HighICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk
FDA (Devices) · 2016-09-21
- HighICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential
FDA (Devices) · 2016-09-21
- HighICU Medical Recalls Transpac IV Bifurcated Kits Due to Leak Risk
FDA (Devices) · 2016-09-21
- HighICU Medical Recalls Transpac IV Trifurcated Kits Due to Leak Risk
FDA (Devices) · 2016-09-21