Recall Z-1241-2019 ยท DWJ System, Thermal Regulating
Bard Medical Division
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, 3170
| Date | Nov 8, 2017 |
| Status | Terminated |
| Reason | Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad. |
| 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 | 7526 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Argentina, Australia, Canada, Saudi Arabia, South Korea, Singapore, Thailand, and Chile |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad Medivance, Inc., Dec 18, 2014 |