Z-0590-2018 Class III Ongoing
FDA device recall Z-0590-2018 was initiated by C.R. Bard, Inc. on June 2, 2017 and is designated Class III. Reason for recall: 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 NDA… The recall status is ongoing. Affected quantity: 128 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2017
- Initiation Date
- June 2, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128 units
Product Description
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
Reason for Recall
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.
Distribution Pattern
Distributed domestically. Distributed internationally to Australia and Belgium.
Code Information
Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021.