ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 210 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 hazard where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 210 units of Bifurcated Kit with 03ml Flush Device for Duke University (Item No. 46094-20). These kits contain the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir system, which is used for periodic blood sampling on patients connected to pressure monitoring lines.
The recall was initiated because the company identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The affected product is distributed nationwide.
Healthcare facilities and consumers should stop using the affected kits immediately and contact ICU Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20 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
- 210
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)
- 3264142
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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