FDA recall Z-0590-2018

C.R. Bard, Inc. · Class III · device

Product

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

Distributed domestically. Distributed internationally to Australia and Belgium.

Key facts

Status
Ongoing
Initiation date
2017-06-02
Report date
2017-12-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0590-2018