Arctic Sun 5000 and Arctic Sun 2000 — Class II medical device recall Z-0760-2016
Terminated recall by C.R. Bard, Inc., reported 2016-02-17, distributed nationwide. Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was conn
| Recall number | Z-0760-2016 |
|---|---|
| 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 | 2015-11-10 |
| Classified | 2016-02-05 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2017-04-21 |
| Distributed | Nationwide (US) |
| Quantity | 1,539 |
Product
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Reason for recall
Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.
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-0760-2016. 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.