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U.S. Department of Health and Human Services

Class 2 Device Recall Medivance Neonatal ArcticGel Pads

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  Class 2 Device Recall Medivance Neonatal ArcticGel Pads see related information
Date Initiated by Firm February 16, 2024
Date Posted March 26, 2024
Recall Status1 Open3, Classified
Recall Number Z-1381-2024
Recall Event ID 94030
510(K)Number K142702  
Product Classification System, thermal regulating - Product Code DWJ
Product Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Code Information REF/UDI-DI/Lot(Expiration Date): 31802/00801741132131/NGGX5390(31Oct2024), NGGX1179(31Oct2024), NGGX1156(31Oct2024), NGHP2415(28Feb2025), NGHP2411(28Feb2025), NGHT1139(31May2025), NGHTY603(31May2025), NGHV4383(31Jul2025), NGHW1507(31Aug2025); 3180202/10801741132138/NGGZ2622(31Dec2024), NGGV1829(31Aug2024), NGGW3254(30Sep2024), NGHQ2940(31Mar2025); 31802C/00801741223457/NGGV1784(31Aug2024)
Recalling Firm/
Manufacturer		 Medivance Inc.
321 S Taylor Ave Unit 200
Louisville CO 80027-3600
Manufacturer Reason
for Recall		 Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
FDA Determined
Cause 2		 Process control
Action On 2/16/24, BD mailed or emailed recall notices to customers who were asked to do the following: 1) Immediately Discontinue Use 2) Immediately quarantine affected pads, record your inventory totals on the Customer Response Form, discard all devices within your facility's control per your facility's procedures. 3) Share this notice with any users of the product within your facilities or with any facility affected product was distributed to. 4) Complete and return the attached Customer Response Form to the BD contact noted on the form. If you require further assistance contact BD Customer Support at 1-844-823-5433. Say "Recall" when prompted M-F 8am -5pm CT.
Quantity in Commerce 1,654
Distribution Worldwide - US Nationwide distribution including in the states of IL, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Australia, Singapore, South Korea, Taiwan, Japan, China, Thailand.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DWJ and Original Applicant = MEDIVANCE, INC.
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