Z-0271-2018Class II

Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4)...

Name: Z-0271-2018 Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4)...
Creator: C.R. Bard, Inc.
Published: 2017-10-16
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2017-10-16 / Terminated / root cause: manufacturing process

FDA source

C.R. Bard, Inc. began a recall of 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... on 2017-10-16. FDA classified it as Class II and gives the reason as "Hydrogel peeling from the pads". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0271-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-16
Posted: 2017-12-20
Terminated: 2020-06-24
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.
Product code: DWJ System, Thermal Regulating
Reason for recall: Hydrogel peeling from the pads.
Root cause tag: manufacturing process
FDA 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: [email protected]). 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
Product codes and lots: Product Code: 31705 Lot # NGBS1063

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0271-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0271-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-20

Product code DWJ

K142702Class IIArctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel PadMedivance, Inc. / cleared 2014-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)