The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1617-2016·Announced 2016-05-18

C.R. Bard Recalls Arctic Sun Temperature Management Systems

C.R. Bard is recalling 2,613 Arctic Sun Temperature Management Systems because electronic components may cause the internal battery to drain prematurely, rendering the device unresponsive.

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 where a defect could render the device unresponsive, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

C.R. Bard, Inc. is recalling 2,613 units of the Arctic Sun Temperature Management System, model 5000, in 100-120V and 220-240V configurations. The product is a thermal regulating system indicated for monitoring and controlling patient temperature.

The recall is due to a defect where the product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery. This battery is responsible for maintaining the system close and Static Random Access Memory (SRAM). The premature drainage could render the device unresponsive upon system startup.

The affected units were distributed worldwide to all 50 U.S. states, the District of Columbia, and numerous international locations including Argentina, Australia, Canada, China, and the United Kingdom. Specific product codes involved are 5000-00-00, 5000-01-01, 5000-01-02, 5000-01-03, 5000-01-04, and 5000-01-05.

The recalled product

Product
Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Temperature Management
Hazard
Affected units
2,613

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 (6)

  • Product Codes - 5000-00-00
  • 5000-01-01
  • 5000-01-02
  • 5000-01-03
  • 5000-01-04
  • 5000-01-05

Distribution

Distributed in 48 states:

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