ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 660 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak hazard. The affected units were distributed nationwide.
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 hazard, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 660 units of Transpac IV Monitoring Kits with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves 1 Bonded (Item No. 46104-75). The recall involves specific SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers.
The recall was initiated because the company identified a potential for leak with these specific kits. The affected products were distributed nationwide. The source text does not specify the exact dates of distribution or the specific lot numbers beyond the codes 3226851 and 3249846.
Healthcare facilities and consumers should check their inventory for the affected Item No. 46104-75 and the associated codes. If the product is found, it should be removed from use and returned to the supplier or the manufacturer for further instructions.
The recalled product
- Product
- Transpac¿ IV Monitoring Kit w/Safeset 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves 1 Bonded, Item No. 46104-75 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 660
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)
- 3226851 3249846
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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