Recall Z-0590-2018— C.R. Bard, Inc.

Name: FDA recall Z-0590-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-02

Class III · Ongoing

Class III FDA medical device recall by C.R. Bard, Inc., initiated 2017-06-02. It names one FDA 510(k) clearance: K142702. Product: Arctic Sun ArcticGel Pads - Medium, Product Code 317-07. 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..

Recalling firm: C.R. Bard, Inc.
Classification: Class III
Status: Ongoing
Initiated: 2017-06-02
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K142702 — Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel PadMedivance, Inc.·cleared 2014-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.