C.R. Bard, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0590-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Arctic Sun ArcticGel Pads - Medium, Product Code 317-07

Product Classification:

Class III

Date Initiated: June 2, 2017

Date Posted: December 13, 2017

Recall Number: Z-0590-2018

Event ID: 77469

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.

Status: Ongoing

Product Quantity: 128 units

Code Information:

Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021.

Distribution Pattern:

Distributed domestically. Distributed internationally to Australia and Belgium.

Voluntary or Mandated:

Voluntary: Firm initiated