Home / Recalls / Bard Medical Division / Z-2536-2018

Z-2536-2018 Class II Terminated

Recalled by Bard Medical Division — Covington, GA

FDA device recall Z-2536-2018 was initiated by Bard Medical Division on June 13, 2018 and is designated Class II. 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. The recall status is terminated (terminated February 16, 2021). Affected quantity: 5608 Units Total.

Recall Details

Product Type
Devices
Report Date
August 1, 2018
Initiation Date
June 13, 2018
Termination Date
February 16, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5608 Units Total

Product Description

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 Pattern

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.

Code Information

Model #5000 Product codes: 5000-00-00, 5000-00-00L, 5000-00-00E, 5000-01-01, 5000-01-01L, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05, 5000-00-06, 5000-01-07, 5000-01-08. All serial numbers are affected.

Other recalls by Bard Medical Division

  • Z-0803-2019 Class II — SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product C (December 13, 2018)
  • Z-0800-2019 Class II — BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing In (December 6, 2018)
  • Z-2943-2018 Class II — Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Produc (March 21, 2018)
  • Z-1241-2019 Class II — Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) (November 8, 2017)

FDA data resources