ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 710 units of Transpac IV transducers with SafeSet Reservoirs due to a potential leak.
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, 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 710 units of Transpac IV Disposable Transducers with 4 ft. cable extension and stopcock without covers (Item No. 42663-01NS). The recall involves specific SafeSet Reservoir and blood sampling kits containing these transducers.
The recall was initiated because the company identified a potential for leak with the affected devices. 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, used on patients where periodic blood sampling is required.
The affected products were distributed nationwide. The source text does not specify the exact dates of distribution or the specific locations where the products were sold. Consumers and healthcare facilities should check their inventory for the affected item number and stop using the products if they match the description.
The recalled product
- Product
- TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHOUT COVERS, Item No. 42663-01NS 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
- 710
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)
- 3265464 3274815 3280993 3288354 3303694
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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