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U.S. Department of Health and Human Services

Class 2 Device Recall ARCTIC SUN ARCTICGEL Pads

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  Class 2 Device Recall ARCTIC SUN ARCTICGEL Pads see related information
Date Initiated by Firm November 08, 2017
Create Date April 27, 2019
Recall Status1 Terminated 3 on September 02, 2020
Recall Number Z-1241-2019
Recall Event ID 82450
510(K)Number K142702  
Product Classification System, thermal regulating - Product Code DWJ
Product Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads:
Description, Catalog Number
a) Intrepid ArcticGel Small Pad Kit, 31705I
b) Intrepid ArcticGel Medium Pad Kit, 31707I
c) Intrepid ArcticGel Large Pad Kit, 31709I
d) Intrepid ArcticGel Universal Pad, 31700I
e) ArcticGel Universal Pad, 31700
f) ArcticGel Universal Pad, 4-pack, 3170004
g) ArcticGel X-Small Pad, 31703
h) ArcticGel X-Small Pad, 2-pack, 3170302
i) ArcticGel Small Pad Kit, 31705
j) ArcticGel Small Pad Kit, 2-pack, 3170502
k) ArcticGel Medium Pad Kit, 31707
l) ArcticGel Medium Pad Kit, 2-pack, 3170702
m) ArcticGel Large Pad Kit, 31709
n) ArcticGel Large Pad Kit, 2-pack, 3170902
o) ArcticGel Small Universal Pad Kit, 31810
p) ArcticGel Small Universal Pad,4-pack, 3180104
q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only)
r) Intrepid ArcticGel Small Pad Kit, 31705I

Product Usage:
The Arctic Sun¿ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun¿ Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.
Code Information Catalog Number / lot number a) Intrepid ArcticGel Small Pad Kit, 31705I / NGAXY602 b) Intrepid ArcticGel Medium Pad Kit, 31707I / NGAXY603 c) Intrepid ArcticGel Large Pad Kit, 31709I / NGAXY604 d) Intrepid ArcticGel Universal Pad, 31700I / NGAXY601 e) ArcticGel Universal Pad, 31700 / NGAW3898, NGAW3055, NGAZ3417, NGBP1302, NGBP2293, NGBQ1040 f) ArcticGel Universal Pad, 4-pack, 3170004 / NGAW2916, NGAW3893, NGAZ3735, NGBP2294, NGBQ1021 g) ArcticGel X-Small Pad, 31703 /  h) ArcticGel X-Small Pad, 2-pack, 3170302 / NGBP0392, NGBN3519 i) ArcticGel Small Pad Kit, 31705 / NGAW3894, NGAW4510, NGAZ2312, NGAZ3312, NGBN2492, NGBP0513 j) ArcticGel Small Pad Kit, 2-pack, 3170502 / NGAW3900, NGAW3059, NGAY4735, NGAZ0554, NGBP0514, NGBP4515 k) ArcticGel Medium Pad Kit, 31707 / NGBN3536, NGBP0512 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 / NGBN3521 m) ArcticGel Large Pad Kit, 31709 /  n) ArcticGel Large Pad Kit, 2-pack, 3170902 /  o) ArcticGel Small Universal Pad Kit, 31810 / NGBP1534 p) ArcticGel Small Universal Pad,4-pack, 3180104 / NGBP1533, NGBP2320 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) / NGBP3712 r) ArcticGel Neonatal Pad, 2-pack, 3180202 / NGBP0393 
Recalling Firm/
Manufacturer		 Bard Medical Division
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact
770-784-6119
Manufacturer Reason
for Recall		 Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.
FDA Determined
Cause 2		 Process control
Action The firm sent a Voluntary Medical Device Product Notification by mail on 11/08/2017. The letter identified the affected product, problem and actions to be taken. The letter provided instruction on the proper way to remove the pad should the hydrogel peels away from the pad.
Quantity in Commerce 7526 units
Distribution Worldwide Distribution - US Nationwide and the countries of Argentina, Australia, Canada, Saudi Arabia, South Korea, Singapore, Thailand, and Chile
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWJ and Original Applicant = MEDIVANCE, INC.
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