ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 205 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or property damage (leakage in a medical device) are rated as Severe (4).
Plain-English summary
ICU Medical, Inc. is recalling 205 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The recall is being conducted because the company identified a potential for leak with these specific kits. The affected products are identified by the code 3274856 65-033-SJ and were distributed nationwide.
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. These kits are used on patients where periodic blood sampling is required.
Healthcare facilities and consumers should stop using the affected kits immediately. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Cath Lab Kit For Elkhart Hosp., Item No. 46078-17 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 electrical currents that can be…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 205
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)
- 3274856 65-033-SJ
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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