C.R. Bard Recalls Arctic Sun 5000 Temperature Management Systems
C.R. Bard is recalling 3,450 Arctic Sun 5000 Temperature Management Systems due to potential failure if used for more than 2,000 hours without preventive maintenance.
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 product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
C.R. Bard, Inc. is recalling 3,450 units of the Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US. The recall covers Product Codes 5000-00-00 & 5000-00-00E with all serial numbers.
The recall is issued because potential failure of the system may occur when continued use exceeds 2,000 system hours without preventive maintenance. The agency has classified this as a Class II recall.
The affected units were distributed nationwide in the United States and internationally to Australia, Korea, Japan, Canada, Hong Kong, China, Singapore, and EMEA. Users should contact C.R. Bard, Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
- Manufacturer
- C.R. Bard, Inc.
- Hazard
- Affected units
- 3,450
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)
- Product Codes 5000-00-00 & 5000-00-00E - All serial numbers
Distribution
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