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 | Ongoing |
| Reason | Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462. |
| Product | Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 |
| Quantity | 128 units |
| Distribution | Distributed domestically. Distributed internationally to Australia and Belgium. |
| Initiated | 2017-06-02 |
| Classified | 2018-02-12 |
| Recall number | Z-0590-2018 |
| 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-0590-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77469/
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