ICU Medical Recalls CADD Yellow Medication Cassette Reservoirs Due to Leakage
ICU Medical is recalling 185,688 CADD Yellow Medication Cassette Reservoirs because they may leak medication at the connector joint, potentially interrupting therapy or causing exposure to harmful agents.
What this means for you
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 is classified as FDA Class II and involves a risk of harm (air embolus, exposure to toxic agents) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ICU Medical, Inc. is recalling 185,688 units of CADD Yellow Medication Cassette Reservoirs with NRFit connectors. The affected product codes are 21-7600-24 and 21-7609-24. The recall is classified as Class II by the FDA.
The recall is being issued because the reservoirs may exhibit medication leakage at the joint between the luer connector and the tubing. This issue could result in a delay or interruption of therapy, under-delivery of medication, exposure to infectious or toxic agents, or an air embolus.
The affected units were distributed worldwide, including nationwide in the United States and in specific countries such as Austria, Australia, Belgium, Costa Rica, Germany, Estonia, Spain, Finland, France, Great Britain, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, and Sweden. Healthcare providers and patients should stop using the affected reservoirs and contact ICU Medical for further instructions.
The recalled product
- Product
- CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-760
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 185,688
Distribution
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