ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leaks.
What this means for you
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, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 20 units of the PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED. CTR (Item No. 46097-33). These kits include the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir system, which is used for periodic blood sampling in patients connected to pressure monitors.
The recall was initiated because the company identified a potential for leaks in certain SafeSet Reservoir and blood sampling kits that contain the Transpac IV transducers. The affected units were distributed nationwide.
Healthcare facilities and consumers should stop using the affected kits immediately and contact ICU Medical, Inc. for instructions on how to return or replace the products. The specific lot codes associated with this recall are 3264147 and 3265574.
The recalled product
- Product
- PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED. CTR, Item No. 46097-33 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 electr
- 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)
- 3264147 3265574
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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