C.R. Bard Recalls Arctic Sun 5000 and 2000 Temperature Monitors
C.R. Bard is recalling Arctic Sun 5000 and 2000 devices because a simulator key could be connected to the patient cable, resulting in improper temperature therapy.
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 and involves the delivery of improper medical therapy to patients, which meets the rubric criteria for a Severe rating due to the potential for significant injury.
Plain-English summary
C.R. Bard, Inc. is recalling the Arctic Sun 5000 and Arctic Sun 2000 devices, which are intended for monitoring and controlling patient temperatures. The recall involves 1,539 units with all lots and serial numbers sold prior to August 2014. These devices were distributed nationwide, including the District of Columbia and 46 states.
The recall was initiated because improper targeted temperature therapy was delivered to patients. This occurred when the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe. The agency has classified this recall as Class II.
Healthcare facilities and consumers should stop using the affected devices immediately and contact C.R. Bard, Inc. for instructions on how to return or replace the units.
The recalled product
- Product
- Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
- Manufacturer
- C.R. Bard, Inc.
- Affected units
- 1,539
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)
- All lots/serial numbers sold prior to August 2014.
Distribution
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