Arctic Sun Temperature Management System — Class II medical device recall Z-1617-2016
Terminated recall by C.R. Bard, Inc., reported 2016-05-18, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The product may contain electronic components that lead to a premature drainage of the internal control panel
| Recall number | Z-1617-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2015-11-09 |
| Classified | 2016-05-06 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2017-06-06 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CY, CZ, DE, ES, FI, FR, GB, GR, HK, IE, IL, IN, IT, JO, JP, KR, KW, LU, MX, MY, NL, NO, OM, PE, PL, PT, QA, RO, RU, SA, SE, SG, SK, TH, TR, TW, ZA |
| Quantity | 2,613 |
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
Reason for recall
The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1617-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.