ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 820 Transpac IV Monitoring Kits with SafeSet Reservoirs 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 is classified as FDA Class II and involves a risk-of-harm product (medical device leak) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling 820 units of the Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, Item No. 42641-06. The product is a disposable extravascular pressure transducer system used to interface between a catheter and a pressure monitor, featuring a blood sampling port.
The recall was initiated because the company identified a potential for leaks in certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The affected units were distributed nationwide.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take. The recall is classified as Class II by the FDA.
The recalled product
- Product
- TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT), Item No. 42641-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer tha
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 820
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)
- 3249806
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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