Z-0271-2018 Class II Terminated
FDA device recall Z-0271-2018 was initiated by C.R. Bard, Inc. on October 16, 2017 and is designated Class II. Reason for recall: Hydrogel peeling from the pads. The recall status is terminated (terminated June 24, 2020). Affected quantity: 24.
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2017
- Initiation Date
- October 16, 2017
- Termination Date
- June 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
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.¿
Reason for Recall
Hydrogel peeling from the pads.
Distribution Pattern
US Distribution to the states of : FL, LA, IL, CA, MO, MN, TX, OK, TN, and NY
Code Information
Product Code: 31705 Lot # NGBS1063