# FDA recall Z-2536-2018

> **Bard Medical Division** · Class II · device recall initiated 2018-06-13.

## Product

Arctic Sun Temperature Management System, Model 5000.     The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of all ages.

## Reason for recall

An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.

## Distribution

Domestic  Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV,   NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.    Worldwide Distribution: Canada, Austria, Bahrain, Belgium, Brazil, Brussels  China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar,   Greece, Guam, Hungary, Iran, Italy, Jordan, Korea, Luxemburg, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK, Vietnam.

## Key facts

- **Recall number:** Z-2536-2018
- **Recalling firm:** Bard Medical Division
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-13
- **Report date:** 2018-08-01
- **Termination date:** 2021-02-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Covington, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2536-2018

## Citation

> AI Analytics. FDA recall Z-2536-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2536-2018. Source: US FDA. Licensed CC0.

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