ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV Monitoring Kits because the SafeSet Reservoir and blood sampling components may 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 hazard where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
ICU Medical, Inc. is recalling 980 units of Transpac IV Monitoring Kits with SafeSet Reservoir and Blood Sampling Port, Item No. 42648-06. The recall is limited to units with lot number 3280989, which were distributed nationwide in the United States.
The company identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The product is an extravascular pressure transducer used to interface between a catheter and a pressure monitor, with a blood sampling system assembled directly to the patient monitoring line.
Healthcare facilities and consumers should stop using the affected units and contact ICU Medical for further instructions.
The recalled product
- Product
- Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient Mount), Item No. 42648-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular…
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — IV Monitoring
- Hazard
- Affected units
- 980
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)
- lot number 3280989
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 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.
See all 24 products in this recall →Related recalls
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