ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
ICU Medical is recalling 20 units of Bifurcated SafeSet Kits with 03mL Flush Devices due to a potential for leaks.
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 poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
ICU Medical, Inc. is recalling 20 units of Bifurcated SafeSet Kits with 03mL Flush Devices, Item No. 46091-75. The affected products are identified by lot number 3281259 and were distributed nationwide in the United States.
The recall was initiated because the company identified a potential for leaks with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. These devices are used as extravascular pressure transducers that interface between a catheter and a pressure monitor, and the SafeSet reservoir system is used for periodic blood sampling on patients.
Healthcare facilities and consumers should stop using the affected units and contact ICU Medical for further instructions.
The recalled product
- Product
- Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: 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…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 20
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 3281259
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.
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Similar recalls
- HighICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
FDA (Devices) · 2016-11-23
- HighICU Medical Recalls Transpac Pressure Transducer Kits Due to Leak Risk
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