ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling specific Transpac IV transducers and SafeSet Reservoir kits due to a potential for 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 involves a medical device with a potential for leak, which poses a risk of harm where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling specific units of the Transpac IV Disposable Transducer with 4 ft. Cable Extension and Stopcock (Item No. 42582-08) and associated SafeSet Reservoir and blood sampling kits. The recall involves 2,310 units that were distributed nationwide.
The recall was initiated because the company identified a potential for leak with these specific products. 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 are identified by the following lot codes: 3260791, 3265428, 3278802, 3284256, 3288262, and 3310777. The source text does not specify further instructions for consumers or healthcare providers regarding the immediate handling of these devices.
The recalled product
- Product
- TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK, Item No. 42582-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 2,310
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)
- 3260791 3265428 3278802 3284256 3288262 3310777
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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