ICU Medical Recalls Transpac Transducer Kits Due to Potential Leak
ICU Medical is recalling 150 units of Transpac transducer kits with SafeSet Reservoirs 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 involves a medical device with a potential leak, which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 150 units of the Transpac Disposable Straight Pressure Transducer (DSPT) kits, Item No. 46076-21, which include a 0.3ml flush device for children's hospitals. The recall is limited to specific lots identified by codes 3245745 and 3256133.
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. These devices are extravascular pressure transducers that interface between a catheter and a pressure monitor, and the SafeSet Reservoir system is used for periodic blood sampling on patients.
The affected products were distributed nationwide. The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR ALL CHILDRENS HOSP., Item No. 46076-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 150
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)
- 3245745 3256133
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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