FDA Medical Device Recalls (openFDA)
Medivance Inc.: Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
- Recall number
- Z-1381-2024
- Recalling firm
- Medivance Inc.
- Product
- Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
- Status
- Open, Classified
- Initiated
- 2024-02-16
- Posted
- 2024-03-26
- Terminated
- not on file
- Reason
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K142702"]
- PMA numbers
- not on file
- Product code
- DWJ
- Firm FEI
- 3003329224
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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