Reported May 8, 2019 · Terminated
Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads
Bard Medical Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Medical Division · 8195 Industrial Blvd NE · Covington, GA · 30014-1497
Is this the product you have?
Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads
18 of 18 products
| # | Product as published |
|---|---|
| 1 | Intrepid ArcticGel Small Pad Kit, 31705I |
| 2 | Intrepid ArcticGel Medium Pad Kit, 31707I |
| 3 | Intrepid ArcticGel Large Pad Kit, 31709I |
| 4 | Intrepid ArcticGel Universal Pad, 31700I |
| 5 | ArcticGel Universal Pad, 31700 |
| 6 | ArcticGel Universal Pad, 4-pack, 3170004 |
| 7 | ArcticGel X-Small Pad, 31703 |
| 8 | ArcticGel X-Small Pad, 2-pack, 3170302 |
| 9 | ArcticGel Small Pad Kit, 31705 |
| 10 | ArcticGel Small Pad Kit, 2-pack, 3170502 |
| 11 | ArcticGel Medium Pad Kit, 31707 |
| 12 | ArcticGel Medium Pad Kit, 2-pack, 3170702 |
| 13 | ArcticGel Large Pad Kit, 31709 |
| 14 | ArcticGel Large Pad Kit, 2-pack, 3170902 |
| 15 | ArcticGel Small Universal Pad Kit, 31810 |
| 16 | ArcticGel Small Universal Pad,4-pack, 3180104 |
| 17 | ArcticGel Neonatal Pad Kit, 31802 (international distribution only) |
| 18 | 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. |
- Lot codes and dates
18 of 18 products
Products covered by this recall # Product as published 1 Intrepid ArcticGel Small Pad Kit, 31705I / NGAXY602 2 Intrepid ArcticGel Medium Pad Kit, 31707I / NGAXY603 3 Intrepid ArcticGel Large Pad Kit, 31709I / NGAXY604 4 Intrepid ArcticGel Universal Pad, 31700I / NGAXY601 5 ArcticGel Universal Pad, 31700 / NGAW3898, NGAW3055, NGAZ3417, NGBP1302, NGBP2293, NGBQ1040 6 ArcticGel Universal Pad, 4-pack, 3170004 / NGAW2916, NGAW3893, NGAZ3735, NGBP2294, NGBQ1021 7 ArcticGel X-Small Pad, 31703 / 8 ArcticGel X-Small Pad, 2-pack, 3170302 / NGBP0392, NGBN3519 9 ArcticGel Small Pad Kit, 31705 / NGAW3894, NGAW4510, NGAZ2312, NGAZ3312, NGBN2492, NGBP0513 10 ArcticGel Small Pad Kit, 2-pack, 3170502 / NGAW3900, NGAW3059, NGAY4735, NGAZ0554, NGBP0514, NGBP4515 11 ArcticGel Medium Pad Kit, 31707 / NGBN3536, NGBP0512 12 ArcticGel Medium Pad Kit, 2-pack, 3170702 / NGBN3521 13 ArcticGel Large Pad Kit, 31709 / 14 ArcticGel Large Pad Kit, 2-pack, 3170902 / 15 ArcticGel Small Universal Pad Kit, 31810 / NGBP1534 16 ArcticGel Small Universal Pad,4-pack, 3180104 / NGBP1533, NGBP2320 17 ArcticGel Neonatal Pad Kit, 31802 (international distribution only) / NGBP3712 18 ArcticGel Neonatal Pad, 2-pack, 3180202 / NGBP0393 - Amount recalled
- 7526 units
Where it was sold
- Nationwide
Why it was recalled
Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.
This product could cause temporary or reversible health problems — stop using it.
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