Z-1241-2019Class II

Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad...

Name: Z-1241-2019 Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad...
Creator: Bard Medical Division
Published: 2017-11-08
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2017-11-08 / Terminated / root cause: manufacturing process

FDA source

Bard Medical Division began a recall of Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit... on 2017-11-08. FDA classified it as Class II and gives the reason as "Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1241-2019
Classification: Class II
Status: Terminated
Initiated: 2017-11-08
Posted: 2019-04-27
Terminated: 2020-09-02
Recalling firm: C.R. Bard Inc
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.
Product code: DWJ System, Thermal Regulating
Reason for recall: Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1241-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1241-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-04-26

Product code DWJ

K142702Class IIArctic 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)