ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 60,560 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.
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 rating.
Plain-English summary
ICU Medical, Inc. is recalling 60,560 units of the Transpac IV Monitoring Kit, Item No. 011-42584-05. The product includes a disposable transducer and a SafeSet Reservoir system used for blood sampling. 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.
The affected units were distributed nationwide. The specific lot codes associated with this recall are: 3192360, 3210327, 3225634, 3242228, 3242233, 3242235, 3242236, 3242237, 3242245, 3242247, 3242248, 3242249, 3242255, 3242260, 3242262, 3242263, 3253912, 3264057, 3264059, 3264062, 3264063, 3273065, 3273070, 3273071, and 3284136.
Healthcare facilities and consumers should stop using the affected products and contact ICU Medical, Inc. for instructions on how to return the units or obtain a replacement.
The recalled product
- Product
- TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 60,560
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.
See all 162 products in this recall →Related recalls
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Similar recalls
- HighICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
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- HighICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk
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