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.

Recall number

Z-0271-2018

Recalling firm

C.R. Bard, Inc.

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.

Status

Terminated

Initiated

2017-10-16

Posted

not on file

Terminated

2020-06-24

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) 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

24

Distribution

US Distribution to the states of : FL, LA, IL, CA, MO, MN, TX, OK, TN, and NY

Lot, serial or model codes

Product Code: 31705 Lot # NGBS1063

510(k) numbers

["K142702"]

PMA numbers

not on file

Product code

DWJ

Firm FEI

1018233

Firm city

Covington

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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