Class II — C.R. Bard, Inc.
| Recalling firm | C. R. Bard, Inc. |
|---|---|
| Registered facility | View this company's 19 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Complaints were received of restricted/inaccurate flow rate. |
| 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. |
| Quantity | 21,412 units |
| Distribution | Worldwide Distribution - Domestic: US Nationwide; Foreign: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil Canada, Chile, China, Colombia, Croatia, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Oman Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, , South Korea, Kuwait, Macedonia, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, … |
| Initiated | 2016-03-04 |
| Classified | 2016-04-14 |
| Terminated | 2017-12-07 |
| Recall number | Z-1395-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — C.R. Bard, Inc. (Z-1395-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73454/
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