ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk
ICU Medical is recalling 75 units of Transpac pressure transducers and SafeSet reservoirs due to a potential leak hazard.
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, which poses a risk of harm to patients. No injuries or illnesses have been reported, and the agency classification is Class II, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 75 units of Transpac Disposable Straight Pressure Transducers (DSPT) and SafeSet Reservoir blood sampling kits. The recall involves Item No. 46068-02, which includes a 0.3ml flush device for Driscoll Foundation Children's Hospital.
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. These devices are extravascular pressure transducers that interface between a catheter and a pressure monitor, converting pressure changes into electrical currents.
The affected units were distributed nationwide. No specific dates, lot numbers, or reported injuries are provided in the source text. Healthcare facilities should stop using the affected devices and contact ICU Medical for further instructions.
The recalled product
- Product
- M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 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
- 75
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)
- 3226619
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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