Device product
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.¿
Z-0271-2018
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 78664
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24
- Official record key
device-enforcement:Z-0271-2018
Official wording
Reason: Hydrogel peeling from the pads.
Code information: Product Code: 31705 Lot # NGBS1063
Distribution pattern: US Distribution to the states of : FL, LA, IL, CA, MO, MN, TX, OK, TN, and NY
Derived failure modes
-
Unknown
Hydrogel peeling from the pads.