Arctic Sun 5000 Temperature Management System — Class II medical device recall Z-3042-2017
Ongoing recall by C.R. Bard, Inc., reported 2017-08-23, distributed nationwide. Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in
| Recall number | Z-3042-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2017-03-31 |
| Classified | 2017-08-16 |
| Reported by FDA | 2017-08-23 |
| Terminated | 2017-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, HK, JP, KR, SG |
| Quantity | 3,450 units |
Product
Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
Reason for recall
Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.
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-3042-2017. 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.