Device product
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
Z-0590-2018
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 77469
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 128 units
- Official record key
device-enforcement:Z-0590-2018
Official wording
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.
Code information: Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021.
Distribution pattern: Distributed domestically. Distributed internationally to Australia and Belgium.
Derived failure modes
-
Labeling or packaging
Label on product box contains the incorrect