Class III — 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 III |
| Status | Terminated |
| Reason | An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected. |
| Product | Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients. |
| Quantity | 64 |
| Distribution | US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland |
| Initiated | 2016-06-30 |
| Classified | 2016-08-05 |
| Terminated | 2017-06-06 |
| Recall number | Z-2345-2016 |
| 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 III recall — C.R. Bard, Inc. (Z-2345-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74609/
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