ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 730 Transpac IV Trifurcated Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.
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 involves a medical device with a potential leak hazard. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).
Plain-English summary
ICU Medical, Inc. is recalling 730 units of the Transpac IV Trifurcated Monitoring Kit, Item No. 42590-08. The recall involves specific lots identified by codes 3226281 and 3264110, which were distributed nationwide.
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. The SafeSet Reservoir system is used for periodic blood sampling on patients connected to the monitoring line.
Healthcare facilities and consumers who possess these specific kits should stop using them and contact ICU Medical for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- TRANSPAC¿ IV TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3 ML SQUEEZE FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42590-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 730
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)
- 3226281 3264110
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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