Recall Z-0271-2018 ยท DWJ System, Thermal Regulating
C.R. Bard, Inc.
Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.
| Date | Oct 16, 2017 |
| Status | Terminated |
| Reason | Hydrogel peeling from the pads. |
| Root cause | Equipment maintenance |
| Action | Bard Medical sent an Urgent: Medical Product Recall letter on October 16, 2017 to all affected customers. Instructions: 1. Check all inventory locations within your institution for ARCTICGEL" Pad(s) Your facility may have received at least one Medivance ARCTICGEL" Small Pad Kit, product code 317-05, with the lot code NGBS1063. Please refer to the diagram on Attachment 1 to help you locate the product number and lot number of your ARCTICGEL" Pad(s). Please remove any identified affected product(s) from your shelves and complete steps 2-4 below. 2.Do not further use any affected product(s) |
| Quantity | 24 |
| Distribution | US Distribution to the states of : FL, LA, IL, CA, MO, MN, TX, OK, TN, and NY |
| 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 |