ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a potential leak in a medical device used for blood sampling and pressure monitoring, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of Transpac IV Monitoring Kits, Item No. 46112-10. The recall involves 2,640 units that were distributed nationwide. The affected products include the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir blood sampling system.
The recall was initiated because the company identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The transducer interfaces between a catheter and pressure monitor, while the reservoir is used for periodic blood sampling on patients.
Healthcare providers and consumers should stop using the affected units. The specific lot codes associated with this recall are 3203493, 3226937, and 3264167. Users should contact ICU Medical for further instructions on how to handle the recalled devices.
The recalled product
- Product
- Transpac¿ IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and Macrodrip, Item No. 46112-10 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 2,640
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)
- 3203493 3226937 3264167
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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