ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 640 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
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 leak, which poses a risk of harm (infection or fluid loss) even though no specific injuries or illnesses are reported in the source text. This aligns with the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 640 units of the Single Line SafeSet Kit with 03ml Flush Device for E.U.S.H.C. (Item No. 46076-25). These kits contain the Transpac Disposable Straight Pressure Transducer (DSPT) and are used for blood sampling in 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 affected units were distributed nationwide.
Healthcare providers and consumers should stop using the affected kits immediately. The source text does not specify further instructions for disposal or replacement, but users should contact the manufacturer or their supplier for guidance.
The recalled product
- Product
- SINGLE LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-25 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 640
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)
- 3176094
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 SafeSet Reservoir Kits Due to Potential Leak
FDA (Devices) · 2016-09-21
- HighICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential
FDA (Devices) · 2016-09-21
- HighICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits
FDA (Devices) · 2016-09-21
- HighICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
FDA (Devices) · 2016-09-21
- HighICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
FDA (Devices) · 2016-09-21
- HighICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk
FDA (Devices) · 2016-09-21