ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
ICU Medical is recalling 180 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 for leak, which poses a risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 180 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The affected products are identified by the codes 3251030 and 3265547. The recall was initiated because the company identified a potential for leak with these specific kits.
The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line, specifically used on patients where periodic blood sampling is required. The Transpac IV transducer is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor by converting pressure changes into electrical currents.
The affected products were distributed nationwide. The source text does not specify the exact dates of distribution or the specific facilities where the products were shipped. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- CATH LAB KIT WITH 03ML FLUSH DEVICE FOR CARLE CLINIC, Item No. 46087-37 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 electrical…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 180
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)
- 3251030 3265547
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.
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