ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 70 units of Transpac IV transducer kits due to a potential leak. The devices are used for blood sampling and pressure monitoring.
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 is classified as FDA Class II, and the hazard involves a potential leak in a medical device used for blood sampling, which poses a risk of harm without reported injuries.
Plain-English summary
ICU Medical, Inc. is recalling 70 units of the Transpac Disposable Straight Pressure Transducer (DSPT) monitoring kits, specifically the SafeSet Reservoir and blood sampling kits. The recall is due to a potential for leak identified in these devices. The product is identified by Item No. 46076-19 and codes 3265508 and 3268507.
The Transpac 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, used on patients where periodic blood sampling is required. The recall is classified as Class II by the FDA.
The affected units were distributed nationwide. Consumers and healthcare facilities should check their inventory for the specific item number and codes listed. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19 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
- 70
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)
- 3265508 3268507
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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