Bard Medical Division: Medical Device Recall in 2019 - (Recall #: Z-1241-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 8, 2017

Date Posted: May 8, 2019

Recall Number: Z-1241-2019

Event ID: 82450

Reason for Recall:

Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.

Status: Terminated

Product Quantity: 7526 units

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

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of Argentina, Australia, Canada, Saudi Arabia, South Korea, Singapore, Thailand, and Chile

Voluntary or Mandated:

Voluntary: Firm initiated