ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 60 units of Transpac IV transducer kits due to a potential leak. The kits were distributed nationwide.
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 leak, which poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 60 units of Monitoring Kits containing the Transpac IV transducer (Item No. 46106-49). The recall is due to a potential for leak with certain SafeSet Reservoir and blood sampling kits. The product code is 3257003.
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line. These kits were distributed nationwide.
Consumers and healthcare facilities should stop using the affected kits and contact ICU Medical, Inc. for further instructions.
The recalled product
- Product
- Monitoring Kit w/TP4, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way Stopcocks, Blue Plugs and Needleless Valve, Item No. 46106-49 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 60
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)
- 3257003
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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