Class 2 Device Recall ArcticGel Pads

• Date Initiated by Firm: October 16, 2017
• Create Date: December 20, 2017
• Recall Status: Terminated on June 24, 2020
• Recall Number: Z-0271-2018
• Recall Event ID: 78664
• 510(K)Number: K142702
• Product Classification: System, thermal regulating - Product Code DWJ
• 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.¿
• Code Information: Product Code: 31705 Lot # NGBS1063
• Recalling Firm/ Manufacturer: C.R. Bard, Inc.; 8195 Industrial Blvd NE; Covington GA 30014-1497
• For Additional Information Contact: Recall Coordinator; 800-793-8110
• Manufacturer Reason for Recall: Hydrogel peeling from the pads.
• FDA Determined 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) 3. If you have unused affected product(s) for return: a. Fill out the Customer Recall and Effectiveness Check Form  Write in the product(s) number and affected lot(s) number (product code 317-05, lot number NGBS1063) in the table provided along with quantities of each, then complete the bottom of the form with your facilitys information. b. Call or email the recall coordinator (using the contact information on the form) to obtain an RCL number to include on the Customer Recall and Effectiveness Check Form. Return the form to the recall coordinator via FAX: 1-770-784-6469 or E-MAIL: bmd.recall@crbard.com). If you cannot Fax or E-mail the form, please call 1-800-793-8110 and report the required information verbally. c. Upon receipt of the Recall & Effectiveness Check Form, the Recall Coordinator will issue you a FedEx shipping label and instructions for the return of the affected product(s). Please mark the outside package as RECALLED PRODUCT and include the RCL number. All product(s) should be returned to the following shipping address. d. BMD will provide replacement products at no charge for your returned, unused, affected product(s) (ARCTICGEL" Small Pad Kits, product code 317-05, lot number NGBS1063). 4.If you have No Affected Product available for return: No further action is needed. BARD¿ ARCTICGEL" Pad lot codes that are not part of affected lot NG
• Quantity in Commerce: 24
• Distribution: US Distribution to the states of : FL, LA, IL, CA, MO, MN, TX, OK, TN, and NY
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DWJ and Original Applicant = MEDIVANCE, INC.