ICU Medical Recalls Transpac IV Bifurcated Kits Due to Leak Risk
ICU Medical is recalling 10 units of Transpac IV Bifurcated Kits with SafeSet Reservoirs due to a potential for leaks.
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 for leaks, 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 10 units of Transpac IV Bifurcated Kits with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve (Item No. 42500-66). The affected products are identified by lot number 3265419 and were distributed nationwide in the United States.
The recall was initiated because ICU Medical identified a potential for leaks 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.
Healthcare providers and consumers should check their inventory for the specific item number and lot number listed above. If the affected units are found, they should be removed from use and returned to ICU Medical, Inc. according to the company's instructions.
The recalled product
- Product
- Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 10
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 3265419
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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