BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature… — Class II medical device recall Z-1395-2016
Terminated recall by C.R. Bard, Inc., reported 2016-04-20, distributed nationwide. Complaints were received of restricted/inaccurate flow rate.
| Recall number | Z-1395-2016 |
|---|---|
| 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 | 2016-03-04 |
| Classified | 2016-04-14 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2017-12-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CY, DE, DK, EG, ES, FI, FR, GB, GR, HR, ID, IE, IL, IN, IS, IT, JO, JP, KR, KW, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, TH, TR, TW, UA, UY, VN, ZA |
| Quantity | 21,412 units |
| Model numbers | 31700 |
Product
BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.
Reason for recall
Complaints were received of restricted/inaccurate flow rate.
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-1395-2016. 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.